# K884866: Temp. Pacing Leads W/Depth Markings TA-1 and TB-1

- Pathway: 510(k) (Traditional)
- Applicant: Oscor Medical Corp.
- Decided: Mar 22, 1989 after 121 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: 1 (1 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.
1 of 1 device in its family (counting itself) has 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 26, 2018 · Class I · Z-0391-2019: During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, 

Source page: https://510kreport.com/device/K884866
Methodology: https://510kreport.com/methodology