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Chariot Guiding Sheath

by Boston Scientific

510(k) K150186

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150186 Date5 Jun 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0392-2016 FDA Class I initiated 19 Nov 2015

    Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientific has received fourteen complaints for shaft separation, four for distal shaft separation. The most severe outcome of this failure is embolism of device fragments.

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  • Withdrawn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
DYB
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 870.1340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Chariot Guiding Sheath is a flexible, tubular device designed to provide a conduit for the introduction of catheters and other interventional devices into the vascular system. It is classified as a Class 2 medical device under product code DYB.

The device was cleared via the FDA 510(k) pathway on June 5, 2015, under K150186, with a traditional clearance and substantially equivalent determination. It is manufactured by Boston Scientific Corp. at One Scimed Pl., Maple Grove, MN 55311, and is intended for use in peripheral vascular procedures.

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Questions

AI-generated answers, 1 Oct 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 Chariot Guiding Sheath used for?

    The Chariot Guiding Sheath is designed to provide a conduit for the introduction of catheters and other interventional devices into the vascular system, specifically intended for use in peripheral vascular procedures as stated in its FDA 510(k) clearance documentation.

  • How is the Chariot Guiding Sheath supplied and is it sterile?

    While the device data does not specify sterility or supply format, as a flexible tubular guiding sheath intended for vascular access, it is typically supplied sterile and for single-use to maintain aseptic conditions during peripheral vascular procedures, consistent with standard clinical practice for such devices.

  • What regulatory pathway was used for the Chariot Guiding Sheath and when was it cleared?

    The Chariot Guiding Sheath was cleared via the FDA 510(k) traditional pathway on June 5, 2015, under submission number K150186, with a substantially equivalent determination, as documented in its authorization details.