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FlexCath Advance Steerable Sheath and Dilator

by Medtronic Cryocath, LP 2 variants

510(k) K183174

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 NumberK183174 Date26 Nov 2018ClearedStatusActive

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  • Withdrawn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
DRA
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.

The FlexCath Advance Steerable Sheath and Dilator is a steerable catheter sheath used to position an ablation catheter during atrial fibrillation procedures. It is a percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and swapping of catheters and wires while preventing air ingress and minimizing blood loss.

The device is supplied by Medtronic Cryocath, LP and has received FDA 510(k) clearance under K183174 and K202620. It is classified as a Class II steerable catheter (product code DRA) under regulation number 870.1280 with special controls. The device is intended for use in cardiovascular procedures and is not described as sterile, single-use, reusable, MRI safe, or with specific storage conditions in the provided data.

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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 FlexCath Advance Steerable Sheath and Dilator used for?

    The FlexCath Advance Steerable Sheath and Dilator is used to position an ablation catheter during atrial fibrillation procedures. It functions as a percutaneous catheter introducer with a valve that allows for the introduction, withdrawal, and swapping of catheters and wires while preventing air ingress and minimizing blood loss.

  • Is the FlexCath Advance Steerable Sheath and Dilator sterile or single-use?

    The provided device data does not specify whether the FlexCath Advance Steerable Sheath and Dilator is sterile, single-use, or reusable. No information about sterility or reuse is included in the specifications or description, so these details cannot be confirmed from the given data.

  • What regulatory pathway was used for the FlexCath Advance Steerable Sheath and Dilator?

    The FlexCath Advance Steerable Sheath and Dilator received FDA 510(k) clearance under submission numbers K183174 and K202620. It is classified as a Class II steerable catheter (product code DRA) under regulation 870.1280 with special controls, based on a traditional 510(k) submission found substantially equivalent to a predicate device.