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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, vascular, for promoting embolization
Product CodeKRD
Regulation Number 870.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ABK BIOMEDICAL INC
  SUBSTANTIALLY EQUIVALENT 2
ARTIO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTVENTIVE MEDICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAIT USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, S.A.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMBOLIC ACCELERATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU YANGSHUN MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
KA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 2
OBSIDIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
SHAPE MEMORY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HAOWEI MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1185 1185
2020 1167 1167
2021 1444 1444
2022 1498 1498
2023 1374 1374
2024 1040 1040

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Failure 1701 1701
Detachment of Device or Device Component 1340 1340
Stretched 934 934
Adverse Event Without Identified Device or Use Problem 759 759
Physical Resistance/Sticking 735 735
Failure to Advance 517 517
Premature Separation 447 447
Break 425 425
Entrapment of Device 356 356
Migration 311 311
Difficult to Advance 299 299
Material Deformation 267 267
Premature Activation 206 206
Positioning Problem 187 187
Difficult to Remove 184 184
Material Twisted/Bent 177 177
Deformation Due to Compressive Stress 167 167
Migration or Expulsion of Device 149 149
Unraveled Material 143 143
Material Separation 107 107
Device Difficult to Setup or Prepare 89 89
Off-Label Use 85 85
Unintended Movement 79 79
Material Integrity Problem 71 71
Device-Device Incompatibility 71 71
Packaging Problem 67 67
Patient Device Interaction Problem 63 63
Difficult or Delayed Separation 63 63
Material Protrusion/Extrusion 59 59
Malposition of Device 58 58
Inadequacy of Device Shape and/or Size 55 55
Difficult or Delayed Positioning 50 50
Activation Problem 48 48
Fracture 45 45
Activation, Positioning or Separation Problem 43 43
Positioning Failure 40 40
Material Rupture 35 35
Difficult to Insert 34 34
Use of Device Problem 29 29
Material Split, Cut or Torn 29 29
Product Quality Problem 29 29
Separation Problem 24 24
Improper or Incorrect Procedure or Method 24 24
Therapy Delivered to Incorrect Body Area 23 23
No Apparent Adverse Event 23 23
Component Missing 20 20
Retraction Problem 19 19
Human-Device Interface Problem 18 18
Difficult to Fold, Unfold or Collapse 17 17
Activation Failure 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4509 4509
No Consequences Or Impact To Patient 1078 1079
No Known Impact Or Consequence To Patient 755 755
Aneurysm 264 264
Foreign Body In Patient 144 144
No Code Available 134 134
Insufficient Information 104 104
Thromboembolism 72 72
Hemorrhage/Bleeding 61 61
Obstruction/Occlusion 58 58
Pain 57 57
Intracranial Hemorrhage 53 53
Device Embedded In Tissue or Plaque 52 52
Stroke/CVA 50 50
Thrombosis/Thrombus 49 49
Ruptured Aneurysm 46 46
Embolism/Embolus 43 43
Ischemia Stroke 41 41
Death 37 37
Ischemia 36 36
Vasoconstriction 35 35
Infarction, Cerebral 28 28
Hematoma 25 25
Perforation of Vessels 23 23
Hypersensitivity/Allergic reaction 22 22
Necrosis 22 22
No Patient Involvement 20 20
Abdominal Pain 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Patient Problem/Medical Problem 18 18
Sepsis 18 18
Inflammation 18 18
Fistula 16 16
Fever 16 16
Low Blood Pressure/ Hypotension 16 16
Paresis 16 16
Unspecified Tissue Injury 15 15
Therapeutic Response, Decreased 15 15
Pseudoaneurysm 15 15
Unspecified Infection 15 15
Convulsion/Seizure 14 14
Rupture 14 14
Foreign Body Embolism 13 13
Abscess 13 13
Hydrocephalus 12 12
Stenosis 12 12
Failure of Implant 12 12
Swelling/ Edema 11 11
Ptosis 11 11
Embolism 11 11

Recalls
Manufacturer Recall Class Date Posted
1 BALT USA, LLC II Feb-08-2024
2 Boston Scientific Corporation I Mar-27-2024
3 Cook Incorporated II Jun-06-2022
4 MICROVENTION INC. II Oct-27-2023
5 Microvention, Inc. II Feb-13-2020
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