The following data is part of a premarket notification filed by Vascutek Ltd with the FDA for Vascutek Gelsoft Plus Ers Vascular Graft.
| Device ID | K202703 |
| 510k Number | K202703 |
| Device Name: | Vascutek Gelsoft Plus ERS Vascular Graft |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | Vascutek Ltd Newmains Avenue Inchinnan, GB Pa4 9rr |
| Contact | Chirag Merchant |
| Correspondent | Chirag Merchant Vascutek Ltd Newmains Avenue Inchinnan, GB Pa4 9rr |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-16 |
| Decision Date | 2021-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881115832 | K202703 | 000 |
| 05037881115825 | K202703 | 000 |