# K011660: Weck Cardiac Pacing Wires

- Pathway: 510(k) (Traditional)
- Applicant: Weck Closure Systems
- Decided: Aug 21, 2001 after 84 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Weck’s preamendment Temporary Cardiac Electrodes: named in the summary without a submission number
- (no number) Ethicon TPW 32 pacing wires: named in the summary without a submission number
- (no number) Ethicon TPW 92 pacing wires: named in the summary without a submission number
- (no number) Medtronic Model 6500 temporary pacing wires: named in the summary without a submission number
- (no number) Medtronic Model 6491 temporary pacing wires: named in the summary without a submission number

## Indications for use
Weck Cardiac Pacing Wires are intended for use in temporary cardiac pacing following cardiac surgery in adult and pediatric patients.

Source page: https://510kreport.com/device/K011660
Methodology: https://510kreport.com/methodology