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Model 5866-34A Pacemaker Lead Adaptor

by Medtronic Vascular

510(k) K883203

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 NumberK883203 Date6 Sep 1988ClearedStatusActive

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  • Withdrawn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
DTB
Device class
Class III
Regulation
21 CFR Part 870.3680
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 Model 5866-34A Pacemaker Lead Adaptor is a Permanent Pacemaker Electrode, designed as an intermediary connector between pacemaker leads and implantable pulse generators. It facilitates electrical continuity and mechanical stability within cardiac pacing systems, ensuring reliable signal transmission for pacing therapy.

This device is intended for single-use in sterile clinical settings, adhering to FDA 510(k) clearance (K883203) under regulation 870.3680. Supplied as a reusable adaptor for cardiovascular procedures, it requires proper handling and storage to maintain sterility and functionality. No MRI safety information is specified, and its use is governed by the original Substantially Equivalent (SESE) determination from 1988.

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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 Model 5866-34A Pacemaker Lead Adaptor in a cardiac pacing system?

    The Model 5866-34A Pacemaker Lead Adaptor acts as an intermediary connector between pacemaker leads and implantable pulse generators. Its role is to ensure reliable electrical continuity and mechanical stability, which are critical for maintaining consistent signal transmission during pacing therapy. This helps to prevent signal loss or disconnection that could compromise the effectiveness of the pacemaker system.

  • Is the Model 5866-34A Pacemaker Lead Adaptor intended for reuse or single-use, and how should it be handled?

    The Model 5866-34A Pacemaker Lead Adaptor is designed for single-use only in sterile clinical settings. Since it is not intended for reuse, proper handling and adherence to sterile techniques are essential to maintain its functionality and prevent contamination. Always follow manufacturer guidelines for storage and preparation to ensure sterility before use.

  • What regulatory pathway was followed for FDA clearance of this device, and when was it determined?

    The Model 5866-34A Pacemaker Lead Adaptor received FDA 510(k) clearance under the classification of Permanent Pacemaker Electrode (product code DTB) via a Traditional 510(k) review. The device was determined to be Substantially Equivalent (SESE) to a legally marketed predicate, with the clearance decision issued on September 6, 1988, following submission on July 28, 1988. The review was conducted by the Cardiovascular (CV) Advisory Committee.

  • Are there any special storage or handling instructions for maintaining the adaptor’s integrity before use?

    While specific storage instructions aren’t detailed in the provided data, since the adaptor is single-use and sterile, it must be stored in a way that preserves sterility until use. This typically includes keeping it in its original packaging, away from moisture, extreme temperatures, or contamination. Always follow the manufacturer’s packaging guidelines to ensure the device remains functional and safe for clinical use.