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, angioplasty, peripheral, transluminal
Regulation Description Percutaneous catheter.
Product CodeLIT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEGO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS,
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD. DBA SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFINITY ANGIOPLASTY BALLOON COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR,INC(FORMERLY D.B.A EV3 INC.,COVIDIEN LLC)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC. (FORMERLY D.B.A. EV3 INC, COVIDIEN LLC.)
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
NATEC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
NEXSTEP MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
QUALIMED USA, LLC.
  SUBSTANTIALLY EQUIVALENT 1
SILK ROAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMA THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
SUMMA THERAPEUTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2405 2405
2020 2443 2443
2021 2492 2492
2022 2155 2155
2023 1808 1808
2024 1914 1914
2025 782 782

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 8528 8528
Burst Container or Vessel 1986 1986
Leak/Splash 785 785
Difficult to Remove 771 771
Detachment of Device or Device Component 750 750
Adverse Event Without Identified Device or Use Problem 460 460
Break 455 455
Inflation Problem 375 375
Deflation Problem 371 371
Material Separation 327 327
Material Deformation 305 305
Difficult to Advance 221 221
Failure to Advance 178 178
Improper or Incorrect Procedure or Method 155 155
Entrapment of Device 144 144
Material Puncture/Hole 127 127
Material Split, Cut or Torn 126 126
Material Twisted/Bent 105 105
Device-Device Incompatibility 93 93
Fluid/Blood Leak 90 90
Retraction Problem 89 89
Fracture 88 88
Material Integrity Problem 87 87
Stretched 64 64
Material Frayed 55 55
Difficult to Insert 52 52
Off-Label Use 52 52
Use of Device Problem 49 49
Difficult to Open or Remove Packaging Material 43 43
Device Dislodged or Dislocated 43 43
Failure to Deflate 36 36
Partial Blockage 30 30
Device Handling Problem 29 29
Device Damaged Prior to Use 27 27
Packaging Problem 27 27
Peeled/Delaminated 26 26
Device Contamination with Chemical or Other Material 26 26
Device Markings/Labelling Problem 25 25
Crack 25 25
Failure to Fold 24 24
Device Damaged by Another Device 23 23
Structural Problem 22 22
Deformation Due to Compressive Stress 21 21
Physical Resistance/Sticking 16 16
Component Missing 14 14
Device Contaminated During Manufacture or Shipping 13 13
Material Fragmentation 12 12
Tear, Rip or Hole in Device Packaging 12 12
Defective Component 12 12
Unraveled Material 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8569 8569
No Consequences Or Impact To Patient 4150 4151
Foreign Body In Patient 195 195
Insufficient Information 191 191
Vascular Dissection 177 177
No Known Impact Or Consequence To Patient 141 141
No Patient Involvement 111 111
Device Embedded In Tissue or Plaque 92 92
Stenosis 84 84
Perforation of Vessels 55 55
Injury 54 54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 53 53
Hematoma 50 50
No Code Available 50 50
Embolism/Embolus 49 49
Hemorrhage/Bleeding 49 49
Obstruction/Occlusion 41 41
Thrombosis/Thrombus 39 39
Patient Problem/Medical Problem 37 37
Restenosis 30 30
Pain 29 29
Unspecified Tissue Injury 22 22
Perforation 20 20
Thrombus 20 20
Death 18 18
Stroke/CVA 17 17
Occlusion 17 17
Pseudoaneurysm 15 15
Embolism 14 14
Unspecified Infection 13 13
Thrombosis 12 12
Fistula 11 11
Great Vessel Perforation 10 10
Rupture 10 10
Reocclusion 10 10
Vasoconstriction 9 9
Extravasation 9 9
Low Blood Pressure/ Hypotension 8 8
Myocardial Infarction 8 8
Arrhythmia 8 8
Swelling/ Edema 7 7
Calcium Deposits/Calcification 7 7
Blood Loss 6 6
Sepsis 6 6
No Information 6 6
Aneurysm 6 6
Bradycardia 6 6
Needle Stick/Puncture 6 6
Ischemia 6 6
Renal Failure 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Jan-30-2020
2 BrosMed Medical Co.,Ltd. II Feb-27-2019
3 Cordis Corporation II Aug-09-2021
4 Cordis Corporation II Feb-28-2020
5 Cordis Corporation II Oct-30-2019
6 Covidien LP II Oct-29-2024
7 Covidien Llc II Feb-03-2022
8 Nucryo Vascular Inc. II Nov-21-2019
9 Ostial Corporation II Aug-17-2021
10 ev3 Inc II Jan-15-2025
11 ev3 Inc. II Sep-30-2020
-
-