# K013598: Reuse Claim for the Bard Electrophysiology Surelink, Templink, and Templink M Extension Cables

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 11, 2002 after 72 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- 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) SureLink Extension Cable: named in the summary without a submission number
- (no number) TempLink Extension Cable: named in the summary without a submission number
- (no number) TempLink M Extension Cable: named in the summary without a submission number

## Indications for use
The SureLink extension cable is indicated for use during electrophysiology studies in conjunction with the appropriate electrode catheter. This cable may be reused subject to the cleaning and sterilization restrictions herein. The TempLink extension cable when used in conjunction with a thermistor configured Stinger/Stinger S catheter is indicated for use during cardiac ablation with set power to 50W. The TempLink M extension cable when used in conjunction with a thermocouple configured Stinger M catheter is indicated for use during cardiac ablation with set power to 50W. These cables may be reused subject to the cleaning and sterilization restrictions herein.

Source page: https://510kreport.com/device/K013598
Methodology: https://510kreport.com/methodology