← Product Code [QJP](/productcode/QJP) · K261176

# Zoom 4S Catheter (K261176)

_Imperative Care, Inc. · QJP · Aug 28, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261176

## Device Facts

- **Applicant:** Imperative Care, Inc.
- **Product Code:** [QJP](/productcode/QJP.md)
- **Decision Date:** Aug 28, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1250
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

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**Source:** [https://fda.innolitics.com/device/K261176](https://fda.innolitics.com/device/K261176)

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