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

510(k) Premarket Notification
  • 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 Classification Name catheter, percutaneous
510(k) Number K010954
Device Name CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
Applicant
CONCENTRIC MEDICAL, INC.
2585 LEGHORN ST.
MOUTIAN VIEW,  CA  94043
Applicant Contact KEVIN MACDONALD
Correspondent
CONCENTRIC MEDICAL, INC.
2585 LEGHORN ST.
MOUTIAN VIEW,  CA  94043
Correspondent Contact KEVIN MACDONALD
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/30/2001
Decision Date 10/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-