The following data is part of a premarket notification filed by Vascutek Ltd. with the FDA for Eptfe Vascular Prosthesis; Sealptfe.
| Device ID | K030999 |
| 510k Number | K030999 |
| Device Name: | EPTFE VASCULAR PROSTHESIS; SEALPTFE |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | VASCUTEK LTD. 6200 JACKSON RD. Ann Arbor, MI 48103 -9300 |
| Contact | Steven Arick |
| Correspondent | Steven Arick VASCUTEK LTD. 6200 JACKSON RD. Ann Arbor, MI 48103 -9300 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881007038 | K030999 | 000 |
| 05037881002002 | K030999 | 000 |