The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Vascusoft (vp1200k) Knitted Vascular Prosthesis.
| Device ID | K910866 |
| 510k Number | K910866 |
| Device Name: | VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VASCUTEK LTD. NEWMAINS AVENUE INCHINNAN RENFREWSHIRE Pa49rr Scotland, GB |
| Contact | Roshan Maini |
| Correspondent | Roshan Maini VASCUTEK LTD. NEWMAINS AVENUE INCHINNAN RENFREWSHIRE Pa49rr Scotland, GB |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-01 |
| Decision Date | 1991-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881020549 | K910866 | 000 |
| 05037881020020 | K910866 | 000 |
| 05037881020327 | K910866 | 000 |
| 05037881020334 | K910866 | 000 |
| 05037881020341 | K910866 | 000 |
| 05037881020358 | K910866 | 000 |
| 05037881020365 | K910866 | 000 |
| 05037881020372 | K910866 | 000 |
| 05037881020389 | K910866 | 000 |
| 05037881020396 | K910866 | 000 |
| 05037881020402 | K910866 | 000 |
| 05037881020419 | K910866 | 000 |
| 05037881020532 | K910866 | 000 |
| 05037881020013 | K910866 | 000 |