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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 3
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
C.R BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CENTERPOINT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
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 VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, IRELAND
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICRO THERAPEUTICS INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
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 3
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 2
TERUMOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRANSIT SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
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 2891
2021 3007 3018
2022 2643 2667
2023 3049 3126
2024 3192 3207
2025 2820 2820

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3359 3362
Adverse Event Without Identified Device or Use Problem 2887 2974
Break 1354 1362
Material Deformation 1151 1154
Detachment of Device or Device Component 947 951
Physical Resistance/Sticking 884 885
Deformation Due to Compressive Stress 790 790
Material Separation 776 777
Leak/Splash 713 714
Material Twisted/Bent 712 713
Difficult to Remove 607 610
Fracture 505 505
Fluid/Blood Leak 503 505
Material Integrity Problem 466 473
Difficult to Advance 409 410
Deflation Problem 375 376
Material Split, Cut or Torn 369 369
Unraveled Material 352 352
Crack 337 337
Failure to Advance 271 271
Inflation Problem 249 249
Entrapment of Device 222 222
Burst Container or Vessel 198 200
Peeled/Delaminated 197 197
Accessory Incompatible 178 182
Material Frayed 165 165
Obstruction of Flow 159 159
Material Puncture/Hole 157 157
Insufficient Information 142 143
Retraction Problem 136 137
Difficult to Insert 136 136
Use of Device Problem 125 127
Device Dislodged or Dislocated 122 122
Mechanical Problem 107 108
Incorrect, Inadequate or Imprecise Result or Readings 97 97
Device Damaged by Another Device 97 97
Packaging Problem 96 98
Device-Device Incompatibility 92 92
Stretched 89 89
Air/Gas in Device 89 91
Improper or Incorrect Procedure or Method 84 85
Unable to Obtain Readings 76 76
Appropriate Term/Code Not Available 73 75
Patient Device Interaction Problem 63 64
Device Damaged Prior to Use 61 61
Positioning Problem 60 60
No Apparent Adverse Event 59 62
Device Contamination with Chemical or Other Material 58 58
Failure to Deflate 55 55
Gas/Air Leak 52 52

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10491 10524
No Consequences Or Impact To Patient 1912 1912
Insufficient Information 865 868
Foreign Body In Patient 498 504
Thrombosis/Thrombus 495 497
Pericardial Effusion 489 492
Vascular Dissection 476 480
Low Blood Pressure/ Hypotension 314 314
Hemorrhage/Bleeding 313 380
Hematoma 270 333
No Known Impact Or Consequence To Patient 257 257
Intracranial Hemorrhage 253 318
Cardiac Perforation 249 250
Cardiac Tamponade 232 232
Perforation of Vessels 222 225
Stroke/CVA 186 187
Air Embolism 164 166
Obstruction/Occlusion 157 158
Device Embedded In Tissue or Plaque 146 148
Vasoconstriction 142 147
Embolism/Embolus 139 140
Perforation 133 135
Non specific EKG/ECG Changes 126 128
Ischemia Stroke 112 112
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 110 110
Cardiac Arrest 106 109
No Patient Involvement 93 93
Rupture 83 83
Thromboembolism 77 78
Pseudoaneurysm 76 77
Swelling/ Edema 74 75
Unspecified Nervous System Problem 72 72
Pain 70 70
Ischemia 68 69
Myocardial Infarction 64 64
Bradycardia 61 62
Arrhythmia 55 56
Stenosis 50 51
Unspecified Tissue Injury 43 43
Ruptured Aneurysm 42 42
Death 40 41
Discomfort 39 39
Transient Ischemic Attack 36 37
Aneurysm 36 36
No Code Available 34 34
High Blood Pressure/ Hypertension 34 34
Heart Block 33 37
Tachycardia 30 31
Headache 30 30
Unspecified Infection 29 29

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 BALT USA, LLC I Oct-24-2025
6 Bard Peripheral Vascular Inc II Oct-08-2020
7 Boston Scientific Corporation I Aug-29-2025
8 Boston Scientific Corporation II Oct-03-2023
9 Boston Scientific Corporation II Aug-25-2022
10 Boston Scientific Corporation II Apr-15-2021
11 Boston Scientific Corporation II Jan-15-2021
12 Cook Inc. II Jun-02-2020
13 Cook Incorporated II Jul-08-2022
14 Cordis US Corp II Mar-13-2025
15 MICROVENTION INC. II Jan-17-2025
16 MICROVENTION INC. III Jun-07-2021
17 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
18 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
19 Medtronic Vascular II Mar-11-2021
20 Merit Medical Systems, Inc. II Jan-02-2024
21 Mivi Neuroscience Inc II Sep-09-2021
22 ROUTE 92 MEDICAL INC I Apr-24-2024
23 Scientia Vascular, Inc. II Mar-13-2023
24 Stryker Neurovascular II May-28-2024
25 Stryker Neurovascular II May-01-2024
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