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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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 737 737

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 763 763
Physical Resistance/Sticking 723 723
Break 635 635
Leak/Splash 218 218
Material Deformation 201 201
Detachment of Device or Device Component 149 149
Material Separation 122 122
Burst Container or Vessel 111 111
Fracture 95 95
Material Integrity Problem 93 93
Difficult to Advance 86 86
Difficult to Remove 85 85
Device Dislodged or Dislocated 81 81
Device Damaged by Another Device 74 74
Entrapment of Device 65 65
Material Twisted/Bent 55 55
Obstruction of Flow 46 46
Packaging Problem 36 36
Fluid/Blood Leak 36 36
No Apparent Adverse Event 31 31
Stretched 30 30
Material Perforation 29 29
Defective Device 27 27
Difficult to Open or Remove Packaging Material 26 26
Device Alarm System 25 25
Unintended Movement 23 23
Material Rupture 21 21
Failure to Advance 20 20
Output Problem 19 19
Audible Prompt/Feedback Problem 18 18
Material Puncture/Hole 18 18
Electrical /Electronic Property Problem 18 18
Difficult to Flush 17 17
Deformation Due to Compressive Stress 17 17
Collapse 15 15
Display or Visual Feedback Problem 14 14
Device Fell 14 14
Contamination /Decontamination Problem 14 14
Crack 13 13
Compatibility Problem 13 13
Suction Problem 12 12
Device Displays Incorrect Message 11 11
Peeled/Delaminated 11 11
Temperature Problem 10 10
Material Split, Cut or Torn 9 9
Unsealed Device Packaging 8 8
Contamination 7 7
Positioning Problem 7 7
Appropriate Term/Code Not Available 6 6
Difficult to Insert 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1681 1681
No Consequences Or Impact To Patient 370 370
Intracranial Hemorrhage 221 221
No Known Impact Or Consequence To Patient 191 191
Foreign Body In Patient 143 143
Insufficient Information 125 125
Hemorrhage/Bleeding 121 121
Ischemia Stroke 73 73
Stroke/CVA 68 68
Unspecified Nervous System Problem 66 66
Device Embedded In Tissue or Plaque 65 65
Thrombosis/Thrombus 62 62
Vasoconstriction 59 59
Hematoma 57 57
Obstruction/Occlusion 57 57
Thromboembolism 55 55
No Patient Involvement 49 49
Ischemia 47 47
Vascular Dissection 46 46
Embolism/Embolus 44 44
Rupture 39 39
Paresis 38 38
Swelling/ Edema 38 38
No Code Available 36 36
Stenosis 35 35
Muscle Weakness 28 28
Pain 27 27
Headache 27 27
Perforation of Vessels 26 26
Pseudoaneurysm 23 23
Hemorrhagic Stroke 22 22
Dysphasia 21 21
Transient Ischemic Attack 20 20
Convulsion/Seizure 20 20
Death 19 19
Fistula 19 19
Visual Disturbances 18 18
Paralysis 18 18
Nervous System Injury 17 17
Unspecified Infection 17 17
Hydrocephalus 16 16
Coma 15 15
Cognitive Changes 15 15
Perforation 15 15
Ruptured Aneurysm 14 14
Cerebral Edema 14 14
Confusion/ Disorientation 13 13
Failure of Implant 12 12
Low Blood Pressure/ Hypotension 11 11
Visual Impairment 11 11

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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