← Product Code [DRA](/productcode/DRA) · K262165

# FARADRIVE™ Steerable Sheath (M004PF21M402) (K262165)

_Boston Scientific Corporation · DRA · Jul 24, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K262165

## Device Facts

- **Applicant:** Boston Scientific Corporation
- **Product Code:** [DRA](/productcode/DRA.md)
- **Decision Date:** Jul 24, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.1280
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

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**Source:** [https://fda.innolitics.com/device/K262165](https://fda.innolitics.com/device/K262165)

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