The following data is part of a premarket notification filed by Vascutek Ltd with the FDA for Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch.
| Device ID | K200955 |
| 510k Number | K200955 |
| Device Name: | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | Vascutek Ltd Newmains Avenue Inchinnan, GB Pa4 9rr |
| Contact | Heidi Forsyth |
| Correspondent | Heidi Forsyth Vascutek Ltd Newmains Avenue Inchinnan, GB Pa4 9rr |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-09 |
| Decision Date | 2020-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881010892 | K200955 | 000 |
| 05037881010632 | K200955 | 000 |
| 05037881010625 | K200955 | 000 |
| 05037881010618 | K200955 | 000 |
| 05037881010465 | K200955 | 000 |
| 05037881010458 | K200955 | 000 |
| 05037881010441 | K200955 | 000 |
| 05037881010434 | K200955 | 000 |
| 05037881010427 | K200955 | 000 |
| 05037881010410 | K200955 | 000 |
| 05037881010663 | K200955 | 000 |
| 05037881010656 | K200955 | 000 |
| 05037881010670 | K200955 | 000 |
| 05037881010687 | K200955 | 000 |
| 05037881010885 | K200955 | 000 |
| 05037881010878 | K200955 | 000 |
| 05037881010861 | K200955 | 000 |
| 05037881010854 | K200955 | 000 |
| 05037881010847 | K200955 | 000 |
| 05037881010830 | K200955 | 000 |
| 05037881010823 | K200955 | 000 |
| 05037881010816 | K200955 | 000 |
| 05037881010700 | K200955 | 000 |
| 05037881010694 | K200955 | 000 |
| 05037881010649 | K200955 | 000 |