# K925099: Possis Medical Myopore Bipolar Sutureless Mycardia

- Pathway: 510(k) (Traditional)
- Applicant: Possis Medical, Inc.
- Decided: Jun 22, 1993 after 257 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 1, 2009 · Not classified · Z-0581-2010: 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.

Source page: https://510kreport.com/device/K925099
Methodology: https://510kreport.com/methodology