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 Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K052282
Device Name VENAFLO II VASCULAR GRAFT
Applicant
BARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE,  AZ  85281
Applicant Contact GLENN NORTON
Correspondent
BARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE,  AZ  85281
Correspondent Contact GLENN NORTON
Regulation Number870.3450
Classification Product Code
DSY  
Date Received08/22/2005
Decision Date 09/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-