The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Preclude Pericardial Membrane.
| Device ID | K012098 |
| 510k Number | K012098 |
| Device Name: | PRECLUDE PERICARDIAL MEMBRANE |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Contact | R. Larry Pratt |
| Correspondent | R. Larry Pratt W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-05 |
| Decision Date | 2001-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H3731PCM10339 | K012098 | 000 |
| H3731PCM10238 | K012098 | 000 |
| H3731PCM10137 | K012098 | 000 |
| H3731PCM10036 | K012098 | 000 |
| H3731PCM00136 | K012098 | 000 |