The following data is part of a premarket notification filed by Intervascular, Inc. with the FDA for Ochsner & Micron Fabric Patch.
| Device ID | K881508 |
| 510k Number | K881508 |
| Device Name: | OCHSNER & MICRON FABRIC PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | INTERVASCULAR, INC. 4906-A CREEKSIDE DR. Clearwater, FL 33520 |
| Contact | Michael P Dayton |
| Correspondent | Michael P Dayton INTERVASCULAR, INC. 4906-A CREEKSIDE DR. Clearwater, FL 33520 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-11 |
| Decision Date | 1988-05-25 |