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Sentra Pacemaker Lead Adaptor

by Cardiac Pacemakers, Inc.

510(k) K843060

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843060 Date20 Sep 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Sentra
510(k) Number
FDA Product Code
DTD
Device Class
Class II
Regulation
21 CFR Part 870.3620
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Sentra is a pacemaker lead adaptor designed for use in cardiovascular applications. It functions as an interface component to facilitate the connection between cardiac leads and rhythm management devices.

This device is classified as a Class 2 cardiovascular device under regulation number 870.3620. It received FDA 510(k) clearance under the traditional pathway with the identifier K843060.

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Questions

AI-generated answers, 21 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 function of the Sentra device?

    The Sentra is a pacemaker lead adaptor designed for cardiovascular applications. It serves as an essential interface component that facilitates the physical and electrical connection between cardiac leads and rhythm management devices.

  • How is the Sentra classified for regulatory purposes?

    The Sentra is classified as a Class 2 cardiovascular device under regulation number 870.3620. It received FDA 510(k) clearance through the traditional pathway, identified by the submission number K843060.

  • Who is the manufacturer of the Sentra lead adaptor?

    The Sentra pacemaker lead adaptor is manufactured by Cardiac Pacemakers, Inc., located in Walker, Michigan.