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Medtronic Model 5301B Test Cable

by Medtronic Vascular

510(k) K904602

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 NumberK904602 Date3 Jan 1991ClearedStatusActive

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  • Withdrawn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
DXY
Device class
Class III
Regulation
21 CFR Part 870.3610
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 Medtronic Model 5301B Test Cable is a Tester, Pacemaker Electrode Function (Product Code DTB), designed to evaluate the functionality of pacemaker electrodes. This device facilitates diagnostic testing by verifying electrical connectivity and performance in pacemaker systems, ensuring proper signal transmission and device operation.

Supplied as a reusable medical device, the Model 5301B Test Cable is intended for use in clinical settings where pacemaker testing is required. It is classified as a Class III device under FDA regulations (CFR Subpart D) and holds a 510(k) clearance (K904602) for substantial equivalence to predicate devices. No sterility or MRI safety information is specified, and its regulatory status is confirmed by the FDA’s Traditional 510(k) review process.

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Questions

AI-generated answers, 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.

  • What is the primary purpose of the Medtronic Model 5301B Test Cable in clinical settings?

    The Medtronic Model 5301B Test Cable is designed specifically to evaluate the functionality of pacemaker electrodes. It helps clinicians verify electrical connectivity and performance in pacemaker systems, ensuring proper signal transmission and overall device operation during diagnostic testing.

  • Is the Medtronic Model 5301B Test Cable intended for single-use or reusable applications?

    The device is explicitly supplied as a reusable medical device, meaning it is intended for repeated use in clinical settings where pacemaker testing is required. Reusability is noted in the product description, so proper cleaning and maintenance protocols should be followed.

  • What regulatory pathway was followed for the FDA clearance of this device?

    The Medtronic Model 5301B Test Cable received FDA clearance through the Traditional 510(k) review process, which confirms its substantial equivalence to a predicate device. The clearance number is K904602, and it falls under the Cardiovascular advisory committee (CV) classification.

  • Are there any specific storage requirements mentioned for the Medtronic Model 5301B Test Cable?

    The provided data does not specify any particular storage requirements for the Medtronic Model 5301B Test Cable. Since it is reusable, it should be stored in a clean, dry environment to maintain its functionality and prevent contamination.