The following data is part of a premarket notification filed by Sulzer Carbomedics, Inc. with the FDA for Patch,pledget And Intracardiac,petp,ptfe,polypropylene.
| Device ID | K972201 |
| 510k Number | K972201 |
| Device Name: | PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Edward E Newton |
| Correspondent | Edward E Newton SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-11 |
| Decision Date | 1998-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881011103 | K972201 | 000 |
| 05037881010434 | K972201 | 000 |
| 05037881010618 | K972201 | 000 |
| 05037881011011 | K972201 | 000 |
| 05037881011028 | K972201 | 000 |
| 05037881011035 | K972201 | 000 |
| 05037881011042 | K972201 | 000 |
| 05037881011059 | K972201 | 000 |
| 05037881011066 | K972201 | 000 |
| 05037881011073 | K972201 | 000 |
| 05037881011080 | K972201 | 000 |
| 05037881011097 | K972201 | 000 |
| 05037881003238 | K972201 | 000 |