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Possis Medical Myopore Bipolar Sutureless Mycardia

by Possis Medical, Inc.

510(k) K925099

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK925099 Date22 Jun 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0581-2010 FDA Unclassified (pre-2012) initiated 1 Sep 2009

    The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.

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  • Withdrawn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, 20 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 Possis Medical Myopore Bipolar Sutureless Myocardia is a Permanent Pacemaker Electrode designed for myocardial attachment without sutures. It employs bipolar technology to secure cardiac tissue, facilitating precise and efficient fixation during cardiac procedures.

This device is intended for use in cardiovascular surgery settings and is classified as a Class III medical device under FDA regulations. Supplied sterile and intended for single-use, it adheres to 870.3680 standards and holds an FDA 510(k) clearance (K925099). Multiple registration numbers (e.g., 2017865, 3002618605) correspond to its authorized variants.

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