← Product Code [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB) · K792172

# PERCUTANEOUS SHEATH INTRO. KIT OR TRAY (K792172)

_Stanco Medical, Inc. · DYB · Nov 13, 1979 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K792172

## Device Facts

- **Applicant:** Stanco Medical, Inc.
- **Product Code:** [DYB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB.md)
- **Decision Date:** Nov 13, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1340
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K792172](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYB/K792172)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
