PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
Device Facts
| Record ID | K930606 |
|---|---|
| Device Name | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER |
| Applicant | Pudenz-Schulte Medical Research Corp. |
| Product Code | GYK · Neurology |
| Decision Date | Sep 10, 1993 |
| 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.
