The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,vascutek Gelsoft Patch,vascutek Thin Wall Carotid Patch.
| Device ID | K963611 |
| 510k Number | K963611 |
| Device Name: | VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | VASCUTEK LTD. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Teena M Augostino |
| Correspondent | Teena M Augostino VASCUTEK LTD. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-10 |
| Decision Date | 1996-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881999227 | K963611 | 000 |
| 05037881010687 | K963611 | 000 |
| 05037881010670 | K963611 | 000 |
| 05037881010656 | K963611 | 000 |
| 05037881010632 | K963611 | 000 |
| 05037881010625 | K963611 | 000 |
| 05037881010465 | K963611 | 000 |
| 05037881010458 | K963611 | 000 |
| 05037881010441 | K963611 | 000 |
| 05037881010427 | K963611 | 000 |
| 05037881010694 | K963611 | 000 |
| 05037881010700 | K963611 | 000 |
| 05037881010892 | K963611 | 000 |
| 05037881010885 | K963611 | 000 |
| 05037881010878 | K963611 | 000 |
| 05037881010861 | K963611 | 000 |
| 05037881010854 | K963611 | 000 |
| 05037881010847 | K963611 | 000 |
| 05037881010830 | K963611 | 000 |
| 05037881010823 | K963611 | 000 |
| 05037881010816 | K963611 | 000 |
| 05037881010410 | K963611 | 000 |