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, Steerable
510(k) Number K091596
Device Name EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
Applicant
Evalve, Inc.
4045 Campbell Ave.
Menlo Park,  CA  94025
Applicant Contact CINDY MORROW
Correspondent
Evalve, Inc.
4045 Campbell Ave.
Menlo Park,  CA  94025
Correspondent Contact CINDY MORROW
Regulation Number870.1280
Classification Product Code
DRA  
Date Received06/02/2009
Decision Date 07/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-