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 K034010
Device Name GELSOFT PLUS ERS
Applicant
Vascutek, Ltd.
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact STEVEN ARICK
Correspondent
Vascutek, Ltd.
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact STEVEN ARICK
Regulation Number870.3450
Classification Product Code
DSY  
Date Received12/24/2003
Decision Date 02/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-