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 Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K921895
Device Name TISSUE PATCH, TISSUE GRAFT
Applicant
Bio-Vascular, Inc.
2670 Patton Rd.
St. Paul,  MN  55113
Applicant Contact BRUCE MACFARLANE
Correspondent
Bio-Vascular, Inc.
2670 Patton Rd.
St. Paul,  MN  55113
Correspondent Contact BRUCE MACFARLANE
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received04/22/1992
Decision Date 11/04/1992
Decision SE - Postmarket Surveillance Required (SESP)
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
-
-