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 wire, guide, catheter
510(k) Number K122590
Device Name RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
Applicant
Terumo Medical Corporation
265 DAVIDSON AVE, STE 320
SOMERSET,  NJ  08873
Applicant Contact STACY A KLUESNER, MS, RAC
Correspondent
Terumo Medical Corporation
265 DAVIDSON AVE, STE 320
SOMERSET,  NJ  08873
Correspondent Contact STACY A KLUESNER, MS, RAC
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/24/2012
Decision Date 03/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-