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 K031916
Device Name GALT MEDICAL GUIDEWIRE
Applicant
GALT MEDICAL CORP.
2475 MERRITT DR.
GARLAND,  TX  75041
Applicant Contact DAVID CATLIN
Correspondent
GALT MEDICAL CORP.
2475 MERRITT DR.
GARLAND,  TX  75041
Correspondent Contact DAVID CATLIN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/20/2003
Decision Date 07/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-