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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 3
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
SUZHOU ZENITH VASCULAR SCITECH LIMITED
  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 381 386
2021 440 447
2022 543 548
2023 829 841
2024 945 946
2025 948 948

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 1307 1309
Adverse Event Without Identified Device or Use Problem 871 881
Break 674 675
Material Deformation 279 281
Leak/Splash 248 249
Detachment of Device or Device Component 163 173
Burst Container or Vessel 116 117
Material Separation 115 116
Difficult to Advance 111 112
Material Integrity Problem 103 103
Fracture 98 98
Difficult to Remove 96 97
Device Damaged by Another Device 90 92
Device Dislodged or Dislocated 83 83
Entrapment of Device 65 66
Packaging Problem 62 62
Material Twisted/Bent 59 60
Unintended Movement 59 59
Obstruction of Flow 48 48
No Apparent Adverse Event 36 37
Stretched 29 30
Material Rupture 29 30
Fluid/Blood Leak 27 27
Defective Device 27 27
Material Perforation 26 26
Deformation Due to Compressive Stress 25 26
Device Alarm System 25 25
Output Problem 24 24
Compatibility Problem 23 23
Difficult to Open or Remove Packaging Material 21 25
Collapse 19 19
Failure to Advance 19 19
Electrical /Electronic Property Problem 18 18
Difficult to Flush 16 16
Device Fell 14 24
Crack 13 13
Contamination /Decontamination Problem 13 13
Retraction Problem 12 12
Display or Visual Feedback Problem 12 12
Material Puncture/Hole 11 11
Device Displays Incorrect Message 11 11
Peeled/Delaminated 10 10
Suction Problem 10 10
Temperature Problem 9 9
Disconnection 9 9
Unsealed Device Packaging 9 9
Material Split, Cut or Torn 8 8
Device Contaminated During Manufacture or Shipping 7 7
Positioning Problem 7 7
Material Too Soft/Flexible 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2638 2654
Intracranial Hemorrhage 249 250
No Consequences Or Impact To Patient 194 198
Foreign Body In Patient 152 154
Insufficient Information 139 144
Hemorrhage/Bleeding 137 139
Ischemia Stroke 113 113
Thrombosis/Thrombus 80 81
No Known Impact Or Consequence To Patient 79 79
Obstruction/Occlusion 75 76
Vasoconstriction 73 73
Unspecified Nervous System Problem 68 70
Stroke/CVA 67 68
Device Embedded In Tissue or Plaque 61 61
Vascular Dissection 59 61
Thromboembolism 58 60
Hematoma 56 56
Embolism/Embolus 54 55
Ischemia 54 54
Stenosis 48 49
Paresis 45 45
Rupture 44 44
Swelling/ Edema 43 43
Headache 35 35
Hemorrhagic Stroke 35 35
Muscle Weakness 33 34
Transient Ischemic Attack 32 32
Pain 27 27
Perforation of Vessels 27 28
Paralysis 27 27
Aneurysm 26 26
Nervous System Injury 26 26
Pseudoaneurysm 25 25
Dysphasia 25 26
Ruptured Aneurysm 23 23
No Patient Involvement 22 23
No Code Available 21 21
Hydrocephalus 20 20
Convulsion/Seizure 20 20
Cognitive Changes 19 20
Visual Disturbances 18 18
Cerebral Edema 17 17
Visual Impairment 17 17
Coma 17 17
Perforation 17 17
Unspecified Infection 16 16
Low Blood Pressure/ Hypotension 15 15
Confusion/ Disorientation 14 14
Fistula 14 14
Failure of Implant 13 13

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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