Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, percutaneous, neurovasculature
Definition To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Product CodeQJP
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMEDICAL BEIJING LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANOXIA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AQURE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
BEND IT TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
CERENOVUS INC.
  SUBSTANTIALLY EQUIVALENT 1
CERENOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CERUS ENDOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJI SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU EASYCESS MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
IMPERATIVE CARE INC.
  SUBSTANTIALLY EQUIVALENT 4
IMPERATIVE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
KAI MEDTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
MADURO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARBLEHEAD MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MARBLEHEAD MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
MIVI NEUROSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
MIVI NEUROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEURAVI LIMITED
  SUBSTANTIALLY EQUIVALENT 2
PENUMBRA, INC
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 3
PERFUZE LTD.
  SUBSTANTIALLY EQUIVALENT 3
Q'APEL MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RIST NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROUTE 92 MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ROUTE 92 MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
ROUTE 92 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
SCIENTIA VASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 16 16
2021 26 26
2022 29 29
2023 72 72
2024 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 54 54
Crack 41 41
Material Separation 30 30
Break 22 22
Fluid/Blood Leak 13 13
Physical Resistance/Sticking 13 13
Material Twisted/Bent 11 11
Deflation Problem 10 10
Difficult to Advance 9 9
Burst Container or Vessel 6 6
Insufficient Information 6 6
Material Deformation 6 6
Difficult to Remove 6 6
Deformation Due to Compressive Stress 5 5
Stretched 4 4
Flaked 3 3
Unsealed Device Packaging 3 3
Failure to Deflate 2 2
Material Too Soft/Flexible 2 2
Failure to Advance 2 2
Fracture 2 2
Entrapment of Device 2 2
Separation Problem 2 2
Material Split, Cut or Torn 2 2
Device-Device Incompatibility 2 2
Material Fragmentation 1 1
Device Damaged by Another Device 1 1
Contamination /Decontamination Problem 1 1
Difficult or Delayed Positioning 1 1
Inflation Problem 1 1
Delivered as Unsterile Product 1 1
Material Rupture 1 1
Expiration Date Error 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Defective Component 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Unintended Movement 1 1
Peeled/Delaminated 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 140 140
Vascular Dissection 15 15
Intracranial Hemorrhage 15 15
Stroke/CVA 10 10
Vasoconstriction 9 9
No Consequences Or Impact To Patient 7 7
Hemorrhage/Bleeding 6 6
Foreign Body In Patient 5 5
Perforation of Vessels 5 5
Ischemia Stroke 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Obstruction/Occlusion 3 3
Pain 3 3
Insufficient Information 2 2
Paresis 2 2
Swelling/ Edema 2 2
Thromboembolism 2 2
Fistula 2 2
Dysphasia 1 1
Hypersensitivity/Allergic reaction 1 1
Implant Pain 1 1
Rupture 1 1
Transient Ischemic Attack 1 1
Paresthesia 1 1
Unspecified Nervous System Problem 1 1
Erythema 1 1
Viral Infection 1 1
Stenosis 1 1
Urinary Frequency 1 1
Device Embedded In Tissue or Plaque 1 1
Cerebral Edema 1 1
Breast Discomfort/Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medos International Sarl I Mar-13-2024
2 ROUTE 92 MEDICAL INC I Apr-24-2024
3 Stryker Neurovascular II May-28-2024
4 Stryker, Inc. II Feb-14-2024
-
-