The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Tissue Patch, Tissue Graft.
| Device ID | K921895 |
| 510k Number | K921895 |
| Device Name: | TISSUE PATCH, TISSUE GRAFT |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Contact | Bruce Macfarlane |
| Correspondent | Bruce Macfarlane BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-22 |
| Decision Date | 1992-11-04 |