• 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 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
ASAHI
  SUBSTANTIALLY EQUIVALENT 6
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Known Device Problem 5
No Information 5
Peeled 3
Detachment of device component 2
Not Applicable 2
Break 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 19

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Microvention, Inc. II Sep-01-2017

-
-