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MYO/CLIP

by Alto Development Corp.

510(k) K821518

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 NumberK821518 Date8 Jul 1982ClearedStatusActive

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  • Withdrawn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
LDF
Device Class
Class II
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 MYO/CLIP is an electrode, pacemaker, temporary device classified under FDA class 2 with product code LDF. It received traditional 510(k) clearance (K821518) on July 8, 1982, and was determined to be substantially equivalent to a predicate device. The device is indicated for cardiovascular use as per the advisory committee classification.

Manufactured by Alto Development Corp., the MYO/CLIP is supplied as a non-sterile, reusable device unless otherwise specified in labeling. It is not MRI conditional unless stated, and no specific sizes, storage conditions, or single-use claims are provided in the data. The device remains authorized under its original 510(k) submission with no additional clearances or approvals indicated.

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