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 guide, wire, catheter, neurovasculature
Regulation Description Catheter guide wire.
Product CodeMOF
Regulation Number 870.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
ARBOR ENDOVASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 2
ARTIRIA MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENLIGHT MEDICAL TECHNOLOGIES (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMPERATIVE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RAPID-MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 2
SCIENTIA VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
SCIENTIA VASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Neurovascular II May-31-2024
-
-