The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Cv Peri-guard And Vascu-guard.
Device ID | K983602 |
510k Number | K983602 |
Device Name: | CV PERI-GUARD AND VASCU-GUARD |
Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Applicant | BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
Contact | Dianna L Geck |
Correspondent | Dianna L Geck BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
Product Code | DXZ |
CFR Regulation Number | 870.3470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-13 |
Decision Date | 1998-11-12 |
Summary: | summary |