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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
Regulation Description Continuous flush catheter.
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
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1
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
2020 381 381
2021 440 440
2022 543 543
2023 831 831
2024 948 948
2025 241 241

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 946 946
Adverse Event Without Identified Device or Use Problem 777 777
Break 571 571
Material Deformation 235 235
Leak/Splash 223 223
Detachment of Device or Device Component 137 137
Burst Container or Vessel 103 103
Material Separation 94 94
Difficult to Advance 91 91
Material Integrity Problem 89 89
Difficult to Remove 80 80
Fracture 80 80
Device Damaged by Another Device 71 71
Device Dislodged or Dislocated 63 63
Material Twisted/Bent 56 56
Entrapment of Device 54 54
Obstruction of Flow 46 46
Unintended Movement 44 44
Packaging Problem 42 42
No Apparent Adverse Event 33 33
Defective Device 26 26
Device Alarm System 25 25
Material Perforation 24 24
Output Problem 23 23
Stretched 23 23
Fluid/Blood Leak 23 23
Difficult to Open or Remove Packaging Material 21 21
Electrical /Electronic Property Problem 18 18
Material Rupture 18 18
Compatibility Problem 18 18
Deformation Due to Compressive Stress 18 18
Failure to Advance 17 17
Collapse 16 16
Difficult to Flush 16 16
Device Fell 14 14
Retraction Problem 12 12
Crack 11 11
Contamination /Decontamination Problem 11 11
Device Displays Incorrect Message 11 11
Peeled/Delaminated 10 10
Suction Problem 10 10
Display or Visual Feedback Problem 10 10
Material Puncture/Hole 9 9
Temperature Problem 9 9
Unsealed Device Packaging 8 8
Material Too Soft/Flexible 7 7
Positioning Problem 7 7
Material Split, Cut or Torn 7 7
Device Contaminated During Manufacture or Shipping 7 7
Appropriate Term/Code Not Available 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2061 2061
Intracranial Hemorrhage 222 222
No Consequences Or Impact To Patient 194 194
Insufficient Information 130 130
Foreign Body In Patient 125 125
Hemorrhage/Bleeding 123 123
Ischemia Stroke 91 91
No Known Impact Or Consequence To Patient 79 79
Unspecified Nervous System Problem 68 68
Thrombosis/Thrombus 65 65
Vasoconstriction 65 65
Stroke/CVA 65 65
Obstruction/Occlusion 61 61
Device Embedded In Tissue or Plaque 58 58
Thromboembolism 56 56
Hematoma 53 53
Vascular Dissection 51 51
Ischemia 48 48
Embolism/Embolus 45 45
Rupture 42 42
Paresis 39 39
Swelling/ Edema 38 38
Headache 38 38
Stenosis 36 36
Pain 29 29
Muscle Weakness 28 28
Perforation of Vessels 25 25
Pseudoaneurysm 24 24
Hemorrhagic Stroke 23 23
Transient Ischemic Attack 22 22
Dysphasia 22 22
No Patient Involvement 22 22
No Code Available 21 21
Convulsion/Seizure 20 20
Visual Disturbances 20 20
Cognitive Changes 18 18
Nervous System Injury 18 18
Paralysis 18 18
Fistula 17 17
Confusion/ Disorientation 16 16
Unspecified Infection 16 16
Hydrocephalus 16 16
Ruptured Aneurysm 15 15
Coma 15 15
Cerebral Edema 15 15
Visual Impairment 13 13
Perforation 13 13
Failure of Implant 13 13
Low Blood Pressure/ Hypotension 12 12
Aneurysm 12 12

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