Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, percutaneous
Regulation Description Percutaneous catheter.
Product CodeDQY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT (ST. JUDE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 9
ALEMBIC, LLC
  SUBSTANTIALLY EQUIVALENT 3
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BASIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CENTERPOINT SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 5
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
CRUZAR MEDSYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1
EOSOLUTIONS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
HAOLANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HEXACATH
  SUBSTANTIALLY EQUIVALENT 1
IMDS OPERATIONS B.V.
  SUBSTANTIALLY EQUIVALENT 7
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO INC.
  SUBSTANTIALLY EQUIVALENT 1
MARVAO MEDICAL DEVICES LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICRO THERAPEUTICS LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC., D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 3
MIVI NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
NITILOOP LTD.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PENDRACARE
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
QXMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
REFLOW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROUTE 92 MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
SEIGLA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHOCKWAVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIMPSON INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRAIT ACCESS TECHNOLOGIES HOLDINGS
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS. INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRANSIT SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K193420  XO Cross Support Catheter
TRANSIT SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 2
TRAVERSE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRISALUS LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
VANTIS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 4
W. L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2889 2889
2021 3009 3009
2022 2646 2646
2023 3062 3125
2024 3202 3202
2025 1648 1648

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3258 3258
Adverse Event Without Identified Device or Use Problem 2686 2749
Break 1278 1278
Material Deformation 1096 1096
Detachment of Device or Device Component 917 917
Physical Resistance/Sticking 860 860
Deformation Due to Compressive Stress 771 771
Material Separation 739 739
Leak/Splash 656 656
Material Twisted/Bent 602 602
Difficult to Remove 558 558
Fracture 470 470
Fluid/Blood Leak 460 460
Material Integrity Problem 414 414
Difficult to Advance 384 384
Deflation Problem 359 359
Material Split, Cut or Torn 343 343
Unraveled Material 335 335
Crack 318 318
Failure to Advance 255 255
Inflation Problem 237 237
Entrapment of Device 204 204
Burst Container or Vessel 184 184
Peeled/Delaminated 179 179
Material Frayed 157 157
Accessory Incompatible 150 150
Material Puncture/Hole 148 148
Obstruction of Flow 147 147
Insufficient Information 140 140
Retraction Problem 134 134
Difficult to Insert 119 119
Device Dislodged or Dislocated 113 113
Use of Device Problem 110 110
Mechanical Problem 92 92
Packaging Problem 91 91
Incorrect, Inadequate or Imprecise Result or Readings 91 91
Device Damaged by Another Device 91 91
Stretched 81 81
Air/Gas in Device 81 81
Improper or Incorrect Procedure or Method 80 80
Device-Device Incompatibility 78 78
Appropriate Term/Code Not Available 62 62
No Apparent Adverse Event 59 59
Patient Device Interaction Problem 56 56
Unable to Obtain Readings 54 54
Device Contamination with Chemical or Other Material 54 54
Failure to Deflate 51 51
Device Damaged Prior to Use 49 49
Positioning Problem 49 49
Gas/Air Leak 44 44

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9718 9718
No Consequences Or Impact To Patient 1912 1912
Insufficient Information 806 806
Foreign Body In Patient 464 464
Vascular Dissection 459 459
Thrombosis/Thrombus 432 432
Pericardial Effusion 424 424
Hemorrhage/Bleeding 282 345
Low Blood Pressure/ Hypotension 261 261
No Known Impact Or Consequence To Patient 257 257
Intracranial Hemorrhage 257 320
Hematoma 253 316
Cardiac Perforation 217 217
Perforation of Vessels 202 202
Cardiac Tamponade 191 191
Stroke/CVA 179 179
Obstruction/Occlusion 157 157
Device Embedded In Tissue or Plaque 144 144
Air Embolism 141 141
Vasoconstriction 140 140
Embolism/Embolus 135 135
Perforation 120 120
Ischemia Stroke 114 114
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 109 109
Non specific EKG/ECG Changes 106 106
No Patient Involvement 93 93
Cardiac Arrest 88 88
Rupture 83 83
Thromboembolism 79 79
Unspecified Nervous System Problem 74 74
Swelling/ Edema 73 73
Pseudoaneurysm 73 73
Ischemia 66 66
Pain 60 60
Myocardial Infarction 60 60
Bradycardia 52 52
Stenosis 51 51
Arrhythmia 49 49
Ruptured Aneurysm 41 41
Unspecified Tissue Injury 40 40
Death 40 40
Aneurysm 35 35
No Code Available 34 34
Transient Ischemic Attack 34 34
Hemorrhagic Stroke 33 33
Headache 32 32
Injury 29 29
Heart Block 29 29
Muscle Weakness 29 29
High Blood Pressure/ Hypertension 28 28

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-21-2025
2 Abbott I Jul-11-2023
3 Abbott II Apr-07-2022
4 Arrow International Inc II Feb-14-2020
5 Bard Peripheral Vascular Inc II Oct-08-2020
6 Boston Scientific Corporation II Oct-03-2023
7 Boston Scientific Corporation II Aug-25-2022
8 Boston Scientific Corporation II Apr-15-2021
9 Boston Scientific Corporation II Jan-15-2021
10 Cook Inc. II Jun-02-2020
11 Cook Incorporated II Jul-08-2022
12 Cordis US Corp II Mar-13-2025
13 MICROVENTION INC. II Jan-17-2025
14 MICROVENTION INC. III Jun-07-2021
15 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
16 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
17 Medtronic Vascular II Mar-11-2021
18 Merit Medical Systems, Inc. II Jan-02-2024
19 Mivi Neuroscience Inc II Sep-09-2021
20 ROUTE 92 MEDICAL INC I Apr-24-2024
21 Scientia Vascular, Inc. II Mar-13-2023
22 Stryker Neurovascular II May-28-2024
23 Stryker Neurovascular II May-01-2024
-
-