K895868 is an FDA 510(k) clearance for the HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE. This device is classified as a Instrument, Shunt System Implantation (Class I - General Controls, product code GYK).
Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on October 31, 1989, 27 days after receiving the submission on October 4, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4545.
| 510(k) Number | K895868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1989 |
| Decision Date | October 31, 1989 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GYK — Instrument, Shunt System Implantation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.4545 |