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FARADRIVE Steerable Sheath

by Boston Scientific

510(k) K233248

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233248 Date11 Dec 2023ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2755-2026 FDA Class II initiated 11 Jun 2026
    • Ongoing Z-2757-2026 FDA Class II initiated 11 Jun 2026
    • Ongoing Z-2756-2026 FDA Class II initiated 11 Jun 2026

    Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DRA
FDA applicant
Boston Scientific Corporation
Device class
Class II
Regulation
21 CFR Part 870.1280
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A steerable sheath is a catheter designed to navigate and position other devices within the cardiovascular system. This device is intended for use in cardiovascular procedures to facilitate access to cardiac anatomy.

The Faradrive Steerable Sheath is a 13Fr unidirectional sheath with a 35 mm reach, 74 cm usable length, and 91 cm overall length. It features a radiopaque distal end, is supplied sterile, and is designated for single-use only.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the FARADRIVE Steerable Sheath used for?

    The FARADRIVE Steerable Sheath is intended for use in cardiovascular procedures to facilitate access to cardiac anatomy by navigating and positioning other devices within the cardiovascular system.

  • How is the FARADRIVE Steerable Sheath supplied and is it reusable?

    The FARADRIVE Steerable Sheath is supplied sterile and is designated for single-use only, meaning it should not be reprocessed or reused after initial use to ensure patient safety and device integrity.

  • What are the key dimensions and features of the FARADRIVE Steerable Sheath?

    The FARADRIVE Steerable Sheath has a 13Fr diameter, 35 mm reach, 74 cm usable length, 91 cm overall length, and features a radiopaque distal end to aid in visualization during procedures.