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, Tracheal, Expandable
510(k) Number K030567
Device Name MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM
Applicant
Vascular Architects, Inc.
1830 Bering Dr.
San Jose,  CA  95112 -4226
Applicant Contact PHYLLIS ELSON
Correspondent
Vascular Architects, Inc.
1830 Bering Dr.
San Jose,  CA  95112 -4226
Correspondent Contact PHYLLIS ELSON
Regulation Number878.3720
Classification Product Code
JCT  
Date Received02/24/2003
Decision Date 03/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-