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FlexCath Select Steerable Sheath (10 French)

by Medtronic Cryocath, LP

510(k) K142684

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 NumberK142684 Date6 Nov 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1276-2015 FDA Class I initiated 23 Feb 2015

    Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The FlexCath Select Steerable Sheath (10 French) is a steerable introducer sheath classified under the nomenclature code DYB. It is designed for percutaneous catheter insertion into blood vessels and cardiac chambers, including access to the left side of the heart via the interatrial septum.

This device is supplied sterile and intended for single-use procedures. It features bi-directional deflection for enhanced maneuverability and is regulated under the FDA 510(k) pathway, with clearance granted in 2014. The sheath is intended for use in electrophysiology procedures and must be handled and stored according to manufacturer instructions to maintain sterility and performance.

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