The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Heyer-schulte Disposable Peritoneal Catheter Passe.
| Device ID | K895868 |
| 510k Number | K895868 |
| Device Name: | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE |
| Classification | Instrument, Shunt System Implantation |
| Applicant | BAXTER HEALTHCARE CORP. 7280 NORTH CALDWELL Niles, IL 60648 |
| Contact | Matthew Nowland |
| Correspondent | Matthew Nowland BAXTER HEALTHCARE CORP. 7280 NORTH CALDWELL Niles, IL 60648 |
| Product Code | GYK |
| CFR Regulation Number | 882.4545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-04 |
| Decision Date | 1989-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830058186 | K895868 | 000 |
| 00382830058193 | K895868 | 000 |
| 30381780072373 | K895868 | 000 |
| 30381780072366 | K895868 | 000 |