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, Intravascular Occluding, Temporary
510(k) Number K172567
Device Name GORE Molding and Occlusion Balloon Catheter
Applicant
W. L. Gore and Associates, Inc.
1505 N Fourth St.
Flagstaff,  AZ  86004
Applicant Contact Jeremiah Andrews
Correspondent
W. L. Gore and Associates, Inc.
1505 N Fourth St.
Flagstaff,  AZ  86004
Correspondent Contact Jeremiah Andrews
Regulation Number870.4450
Classification Product Code
MJN  
Date Received08/25/2017
Decision Date 01/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-