The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Vascu-guard.
Device ID | K942010 |
510k Number | K942010 |
Device Name: | VASCU-GUARD |
Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Applicant | BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
Contact | Bruce A Macfarlane |
Correspondent | Bruce A Macfarlane BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
Product Code | DXZ |
CFR Regulation Number | 870.3470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-25 |
Decision Date | 1994-07-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VASCU-GUARD 86072412 4765157 Live/Registered |
Synovis Life Technologies, Inc. 2013-09-23 |
VASCU-GUARD 74518571 1898781 Live/Registered |
SYNOVIS LIFE TECHNOLOGIES, INC. 1994-04-29 |