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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, vessel, for percutaneous catheterization
Product CodeDRE
Regulation Number 870.1310
Device Class 2


Premarket Reviews
ManufacturerDecision
ARSTASIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 4
BIOTEQUE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDIACASSIST INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
COOK VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC.
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MC3 INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP ( MEDICAL COMPONENTS)
  SUBSTANTIALLY EQUIVALENT 1
MEDRON, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SUMMIT ACCESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ULTRASONIX MEDICAL CORPATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
XCARDIA INNOVATION LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 80 80
2015 82 82
2016 84 84
2017 101 101
2018 126 126
2019 144 144
2020 120 120
2021 115 1579
2022 136 136
2023 392 392
2024 204 204

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 501 1233
Fracture 207 207
Material Separation 152 152
Break 113 235
Difficult to Remove 110 110
Detachment of Device or Device Component 109 109
Physical Resistance/Sticking 102 224
Device-Device Incompatibility 78 78
Device Contamination with Chemical or Other Material 66 66
Difficult to Advance 50 50
Material Deformation 49 49
Positioning Problem 43 43
Detachment Of Device Component 42 42
Entrapment of Device 39 39
Defective Device 38 38
Material Integrity Problem 27 27
Insufficient Information 22 22
Mechanical Jam 19 385
Crack 16 16
Material Fragmentation 16 16
Material Frayed 15 15
Unraveled Material 15 15
Difficult to Insert 15 15
Appropriate Term/Code Not Available 14 14
Failure to Advance 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Sharp Edges 12 12
Device Operates Differently Than Expected 12 12
Fluid/Blood Leak 10 10
Deformation Due to Compressive Stress 10 10
Stretched 10 10
Device Damaged by Another Device 9 9
Component or Accessory Incompatibility 9 9
Material Split, Cut or Torn 9 9
Migration or Expulsion of Device 9 9
Use of Device Problem 9 9
Packaging Problem 8 8
Retraction Problem 8 8
Sticking 8 8
Device Dislodged or Dislocated 8 8
Torn Material 8 8
Leak/Splash 8 8
Loss of or Failure to Bond 7 7
Material Twisted/Bent 7 7
Failure to Cut 7 129
Unsealed Device Packaging 5 5
Migration 5 5
Display or Visual Feedback Problem 5 5
Material Puncture/Hole 4 4
Tear, Rip or Hole in Device Packaging 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 312 922
Foreign Body In Patient 207 329
Pericardial Effusion 155 399
No Consequences Or Impact To Patient 144 144
Low Blood Pressure/ Hypotension 132 132
Perforation of Vessels 104 714
Great Vessel Perforation 101 345
No Known Impact Or Consequence To Patient 101 101
Cardiac Perforation 68 68
Cardiac Tamponade 67 67
Iatrogenic Source 59 181
Device Embedded In Tissue or Plaque 57 57
Hemorrhage/Bleeding 56 56
Thrombosis/Thrombus 52 52
Death 50 172
No Code Available 40 40
Hematoma 29 29
Perforation 27 27
Vascular Dissection 22 22
Insufficient Information 22 22
Injury 20 20
Laceration(s) 20 20
Embolism 18 18
No Patient Involvement 17 17
Cardiac Arrest 14 14
Blood Loss 13 13
Atrial Perforation 12 12
Unspecified Infection 11 11
Air Embolism 11 11
Arrhythmia 9 9
Pseudoaneurysm 9 9
Foreign body, removal of 9 9
Calcium Deposits/Calcification 7 7
Pleural Effusion 7 7
No Information 7 7
Discomfort 7 7
Non specific EKG/ECG Changes 7 7
Surgical procedure, additional 6 6
Pain 6 6
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Vasoconstriction 5 5
Rupture 5 5
Tissue Damage 5 5
Asystole 4 4
Ventricular Fibrillation 4 4
Tachycardia 4 4
Hypoxia 4 4
Hemothorax 4 4
Intimal Dissection 4 4
Pulmonary Embolism 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Mar-21-2024
2 Argon Medical Devices, Inc II Aug-14-2020
3 Argon Medical Devices, Inc II Mar-01-2016
4 Argon Medical Devices, Inc II Jun-02-2010
5 Argon Medical Devices, Inc III Feb-02-2010
6 Boston Scientific Corporation II Nov-21-2011
7 Cardiac Assist, Inc II Apr-23-2021
8 Cordis Corporation II Jul-15-2021
9 Cordis Corporation II Mar-15-2016
10 Galt Medical Corp II May-11-2010
11 Galt Medical Corporation II Jul-27-2018
12 Maquet Cardiovascular Us Sales, Llc II Mar-27-2020
13 Merit Medical Systems, Inc. II Jun-22-2015
14 Merit Medical Systems, Inc. II Dec-14-2009
15 Procedure Products, Inc. II Dec-01-2015
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