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 clamp, vascular
510(k) Number K981624
Device Name FLO-THRU
Applicant
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Applicant Contact D.E. GARDNER
Correspondent
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Correspondent Contact D.E. GARDNER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received05/07/1998
Decision Date 08/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-