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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name introducer, catheter
510(K) Number K121234
Device Name GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
Applicant
W. L. GORE & ASSOCIATES, INC.
3450 kiltie lane
p.o. box 2400
flagstaff,  AZ  86003 2400
Contact alicia l hemphill
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/24/2012
Decision Date 11/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-