← Product Code [GYK](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK) · K930606

# PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (K930606)

_Pudenz-Schulte Medical Research Corp. · GYK · Sep 10, 1993 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K930606

## Device Facts

- **Applicant:** Pudenz-Schulte Medical Research Corp.
- **Product Code:** [GYK](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK.md)
- **Decision Date:** Sep 10, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4545
- **Device Class:** Class 1
- **Review Panel:** Neurology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K930606](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/GYK/K930606)

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