← Product Code [QJP](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP) · K254046

# BosCATH Support Catheter (K254046)

_Sonorous NV, Inc. · QJP · Apr 21, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K254046

## Device Facts

- **Applicant:** Sonorous NV, Inc.
- **Product Code:** [QJP](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP.md)
- **Decision Date:** Apr 21, 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/submissions/NE/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K254046](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QJP/K254046)

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