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FlexCath Select Steerable Shealth and Dilator

by Medtronic Cryocath, LP

510(k) K163268

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK163268 Date2 Feb 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 26 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 and Dilator is a cardiovascular device designed to facilitate the introduction of various cardiovascular catheters into the heart. It provides steerable access to assist in the positioning of catheters during cardiac procedures.

This device is manufactured by Medtronic Cryocath, LP and received FDA 510(k) clearance on February 2, 2017. It is classified as a Class 2 medical device under product code DYB.

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Questions

AI-generated answers, 26 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 primary function of the FlexCath Select Steerable Sheath and Dilator?

    This device is designed to facilitate the introduction of various cardiovascular catheters into the heart. It provides steerable access to assist clinicians in the precise positioning of these catheters during cardiac procedures.

  • What is the regulatory status of this device?

    The FlexCath Select Steerable Sheath and Dilator received FDA 510(k) clearance on February 2, 2017. It is classified as a Class 2 medical device under product code DYB.

  • Who is the manufacturer of the FlexCath Select system?

    The device is manufactured by Medtronic Cryocath, LP, located in Mounds View, Minnesota.