HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
Device Facts
| Record ID | K895868 |
|---|---|
| Device Name | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE |
| Applicant | Baxter Healthcare Corp |
| Product Code | GYK · Neurology |
| Decision Date | Oct 31, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4545 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.