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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheters, transluminal coronary angioplasty, percutaneous
Regulation Description Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
Definition A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Product CodeLOX
Regulation Number 870.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN TT MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NATEC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ORBUSNEICH MEDICAL TRADING INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K223189  Firefighter™ NC Pro PTCA Balloon Catheter
SINO MEDICAL SCIENCES TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
SIS MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1974 1974
2021 1738 1741
2022 1816 1817
2023 1720 1720
2024 1804 1804
2025 1639 1639

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5851 5852
Difficult to Remove 1182 1182
Difficult to Advance 991 991
Break 916 916
Adverse Event Without Identified Device or Use Problem 873 873
Material Separation 595 595
Failure to Advance 586 586
Deflation Problem 560 560
Improper or Incorrect Procedure or Method 498 498
Inflation Problem 357 358
Burst Container or Vessel 343 343
Material Deformation 329 329
Detachment of Device or Device Component 329 331
Leak/Splash 281 281
Entrapment of Device 238 238
Failure to Deflate 166 166
Deformation Due to Compressive Stress 121 121
Material Split, Cut or Torn 120 120
Material Integrity Problem 114 114
Fracture 96 96
Off-Label Use 75 75
Failure to Fold 66 66
Device Markings/Labelling Problem 65 65
Defective Device 36 36
Physical Resistance/Sticking 31 31
Stretched 31 31
Material Puncture/Hole 28 28
Use of Device Problem 28 28
Contamination 24 24
Device-Device Incompatibility 23 23
Difficult to Open or Remove Packaging Material 22 22
Device Dislodged or Dislocated 21 21
Difficult to Insert 19 19
Device Contamination with Chemical or Other Material 17 17
Device Damaged by Another Device 16 16
Product Quality Problem 14 14
Component Missing 14 14
Packaging Problem 13 13
Illegible Information 12 12
Unintended System Motion 12 12
Unsealed Device Packaging 11 11
Positioning Problem 11 11
Insufficient Information 10 10
Tear, Rip or Hole in Device Packaging 10 10
Difficult or Delayed Positioning 8 8
Obstruction of Flow 8 8
Material Twisted/Bent 7 7
Material Fragmentation 7 7
Patient-Device Incompatibility 7 7
Device Misassembled During Manufacturing /Shipping 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7448 7448
No Consequences Or Impact To Patient 1720 1720
Insufficient Information 319 320
Vascular Dissection 239 239
Myocardial Infarction 189 189
Foreign Body In Patient 147 148
Cardiac Arrest 133 133
Obstruction/Occlusion 127 127
Device Embedded In Tissue or Plaque 118 118
Perforation of Vessels 117 117
Cardiogenic Shock 115 115
Hemorrhage/Bleeding 92 92
No Patient Involvement 91 91
Heart Failure/Congestive Heart Failure 90 90
Low Blood Pressure/ Hypotension 85 85
No Known Impact Or Consequence To Patient 74 74
Perforation 64 65
Arrhythmia 60 60
Hematoma 58 59
Embolism/Embolus 53 53
Chest Pain 48 48
Unspecified Kidney or Urinary Problem 45 45
Angina 43 43
Ischemia 43 43
Non specific EKG/ECG Changes 39 39
Air Embolism 37 37
Thrombosis/Thrombus 35 35
Unspecified Heart Problem 28 28
Bradycardia 25 25
Death 23 23
Injury 20 20
Unspecified Tissue Injury 19 19
Pain 17 17
Pericardial Effusion 17 17
Cardiac Tamponade 17 17
No Code Available 15 15
Ventricular Fibrillation 15 15
High Blood Pressure/ Hypertension 14 14
Tachycardia 13 13
Stenosis 13 13
Vasoconstriction 11 11
Restenosis 10 10
Atrial Fibrillation 9 9
Pulmonary Edema 7 7
Occlusion 7 7
Dyspnea 7 7
Unspecified Infection 7 7
Extravasation 6 7
Shock 6 6
Retroperitoneal Hemorrhage 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I Feb-14-2020
2 Medtronic Inc II Aug-01-2022
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