# K132253: Removable Patient Leads Ecg Cable

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Dec 16, 2013 after 150 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
Longest line of descent: 1 generation back to K771645 (1977). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771645: Electrocardiographic Cablhs & Lead Wire, Tronomed, Inc. (1977) Summary page 1.

## Most influential descendants
- K172591: Fixed Patient Leads ECG Cable (Model 3153) (2017), 0 descendants of its own

## Indications for use
The BSC Removable Patient Leads ECG Cable is used to transmit signals from patient-connected electrodes or transducers to electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. ECG cables are supplied non-sterile and are not sterilizable; they are reusable devices and are recommended to be used by trained operators in a medical environment. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

Source page: https://510kreport.com/device/K132253
Methodology: https://510kreport.com/methodology