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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, continuous flush
Product CodeKRA
Regulation Number 870.1210
Device Class 2


Premarket Reviews
ManufacturerDecision
ABLATIVE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AGILE DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
BEND IT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
MERCATOR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUATICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
SMARTWISE SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TRANSIT SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
TRISALUS LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 2
VASCUPATENT MEDICAL (SHENZHEN) CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
VVT MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 418 418
2020 381 381
2021 440 440
2022 543 543
2023 831 831
2024 528 528

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 674 674
Physical Resistance/Sticking 665 665
Break 613 613
Leak/Splash 208 208
Material Deformation 187 187
Detachment of Device or Device Component 143 143
Material Separation 122 122
Burst Container or Vessel 106 106
Material Integrity Problem 91 91
Fracture 89 89
Device Dislodged or Dislocated 77 77
Difficult to Advance 77 77
Difficult to Remove 74 74
Device Damaged by Another Device 71 71
Entrapment of Device 65 65
Material Twisted/Bent 50 50
Obstruction of Flow 41 41
Fluid/Blood Leak 36 36
Packaging Problem 34 34
Stretched 30 30
No Apparent Adverse Event 29 29
Material Perforation 29 29
Defective Device 27 27
Difficult to Open or Remove Packaging Material 26 26
Device Alarm System 25 25
Failure to Advance 19 19
Material Rupture 18 18
Electrical /Electronic Property Problem 18 18
Audible Prompt/Feedback Problem 18 18
Unintended Movement 18 18
Material Puncture/Hole 18 18
Deformation Due to Compressive Stress 17 17
Output Problem 16 16
Difficult to Flush 15 15
Collapse 15 15
Display or Visual Feedback Problem 14 14
Contamination /Decontamination Problem 14 14
Device Fell 14 14
Compatibility Problem 13 13
Crack 13 13
Suction Problem 12 12
Peeled/Delaminated 11 11
Device Displays Incorrect Message 11 11
Material Split, Cut or Torn 9 9
Temperature Problem 9 9
Positioning Problem 7 7
Contamination 7 7
Unsealed Device Packaging 7 7
Device Difficult to Setup or Prepare 6 6
Difficult to Insert 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1563 1563
No Consequences Or Impact To Patient 370 370
Intracranial Hemorrhage 198 198
No Known Impact Or Consequence To Patient 191 191
Foreign Body In Patient 135 135
Insufficient Information 121 121
Hemorrhage/Bleeding 109 109
Stroke/CVA 68 68
Device Embedded In Tissue or Plaque 65 65
Unspecified Nervous System Problem 60 60
Vasoconstriction 59 59
Ischemia Stroke 54 54
Obstruction/Occlusion 53 53
Thrombosis/Thrombus 51 51
Hematoma 50 50
No Patient Involvement 49 49
Thromboembolism 48 48
Ischemia 44 44
Vascular Dissection 43 43
Embolism/Embolus 39 39
Rupture 37 37
No Code Available 36 36
Swelling/ Edema 34 34
Stenosis 31 31
Paresis 30 30
Perforation of Vessels 24 24
Pain 23 23
Pseudoaneurysm 21 21
Muscle Weakness 21 21
Headache 20 20
Death 19 19
Dysphasia 18 18
Unspecified Infection 16 16
Convulsion/Seizure 15 15
Paralysis 15 15
Hydrocephalus 15 15
Transient Ischemic Attack 14 14
Perforation 14 14
Fistula 14 14
Coma 13 13
Visual Disturbances 13 13
Failure of Implant 12 12
Low Blood Pressure/ Hypotension 11 11
Confusion/ Disorientation 11 11
Nervous System Injury 10 10
Cognitive Changes 10 10
Cardiac Arrest 10 10
Arrhythmia 10 10
Visual Impairment 9 9
Unintended Radiation Exposure 9 9

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Feb-07-2024
2 Boston Scientific Corporation II Dec-17-2020
3 Cook Inc. I Dec-09-2019
4 Merit Medical Systems, Inc. II Jan-02-2024
5 Micro Therapeutics, Inc. II Aug-18-2022
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