The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Acuseal Cardiovascular Patch.
| Device ID | K984526 |
| 510k Number | K984526 |
| Device Name: | ACUSEAL CARDIOVASCULAR PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. Flagstaff, AZ 86002 -0500 |
| Contact | Timothy J Rynn |
| Correspondent | Timothy J Rynn W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. Flagstaff, AZ 86002 -0500 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132600946 | K984526 | 000 |
| 00733132600939 | K984526 | 000 |
| 00733132600922 | K984526 | 000 |
| 00733132600915 | K984526 | 000 |
| 00733132600908 | K984526 | 000 |
| 00733132600892 | K984526 | 000 |