The following data is part of a premarket notification filed by Intervascular, Inc. with the FDA for Ultra Low Porosity Dacron Woven Patch.
| Device ID | K921659 |
| 510k Number | K921659 |
| Device Name: | ULTRA LOW POROSITY DACRON WOVEN PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater, FL 33760 -3130 |
| Contact | Denise Eng |
| Correspondent | Denise Eng INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater, FL 33760 -3130 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-07 |
| Decision Date | 1992-11-25 |