# K803086: Myowire-Atemporary Cardiac Pacing Wire

- Pathway: 510(k) (Traditional)
- Applicant: Craig & Craig, Inc.
- Decided: Jul 1, 1981 after 205 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: 3 (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
- Apr 8, 2024 · Class II · Z-2993-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat
- Apr 8, 2024 · Class II · Z-2991-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat
- Jun 21, 2019 · Class II · Z-2098-2019: Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.

Source page: https://510kreport.com/device/K803086
Methodology: https://510kreport.com/methodology