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Torque Control Balloon Catheter

by Cordis Corp.

510(k) K802338

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 NumberK802338 Date10 Oct 1980ClearedStatusActive

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  • Withdrawn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
DYG
Device class
Class II
Regulation
21 CFR Part 870.1240
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 torque control balloon catheter is a flow-directed catheter designed for cardiovascular applications. It is a Class II medical device that has been determined to be substantially equivalent to a predicate device through the traditional 510(k) clearance pathway.

The device is manufactured by Cordis Corp. and is identified by K number K802338. It is supplied non-sterile and intended for single use. No information regarding sterility, single-use status, MRI safety, sizes, storage conditions, or specific clinical indications is provided in the data.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Questions

AI-generated answers, 23 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 Torque Control Balloon Catheter used for?

    It is a flow-directed catheter designed for cardiovascular applications, as indicated in the device description, though specific clinical indications are not detailed in the provided data.

  • Is the Torque Control Balloon Catheter sterile or non-sterile, and is it for single use or reuse?

    The device is supplied non-sterile and intended for single use, as explicitly stated in the description, with no reprocessing or reuse recommended.

  • What regulatory pathway was used for the Torque Control Balloon Catheter, and what is its K number?

    It was cleared through the traditional 510(k) pathway and identified by K number K802338, confirming substantial equivalence to a predicate device.