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 K063210
Device Name ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488
Applicant
MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT
1015 GRAMSIE RD
SHOREVIEW,  MN  55126 -3082
Applicant Contact MICHELLE NIVALA
Correspondent
MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT
1015 GRAMSIE RD
SHOREVIEW,  MN  55126 -3082
Correspondent Contact MICHELLE NIVALA
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/23/2006
Decision Date 03/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-