The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Acuseal Vascular Graft.
| Device ID | K130215 |
| 510k Number | K130215 |
| Device Name: | GORE ACUSEAL VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. Flagstaff, AZ 86003 -3000 |
| Contact | Michael Ivey |
| Correspondent | Michael Ivey W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. Flagstaff, AZ 86003 -3000 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132634811 | K130215 | 000 |
| 00733132626984 | K130215 | 000 |
| 00733132626960 | K130215 | 000 |
| 00733132622597 | K130215 | 000 |
| 00733132622573 | K130215 | 000 |
| H373ECH060040A38 | K130215 | 000 |