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FOCUS Balloon Dilatation Catheter

by Cardiovascular Dynamics, Inc. 2 variants

510(k) K952064

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 NumberK952064 Date21 Jun 1995ClearedStatusActive

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  • Withdrawn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
LIT
Device Class
Class II
Regulation
21 CFR Part 870.1250
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 FOCUS Balloon Dilatation Catheter is a medical device used for balloon dilatation procedures. It is classified as a Class II device under the regulation number 870.1250.

The device is supplied sterile and intended for single use. It is not MRI safe. The device is regulated by the FDA under 510(k) clearance.

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See all devices from Cardiovascular Dynamics, Inc. →

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 FOCUS Balloon Dilatation Catheter used for?

    This device is intended for balloon dilatation procedures, a process used to widen narrowed or blocked blood vessels.

  • Is the FOCUS Balloon Dilatation Catheter sterile?

    Yes, the device is supplied sterile and is intended for single use, meaning it should not be reused on another patient.

  • Is the FOCUS Balloon Dilatation Catheter MRI safe?

    No, the device is not MRI safe, so it should not be used in environments with strong magnetic fields.

  • How is the FOCUS Balloon Dilatation Catheter regulated?

    It is a Class II medical device regulated by the FDA under 510(k) clearance, which means it was found to be substantially equivalent to a predicate device.