# K172591: Fixed Patient Leads ECG Cable (Model 3153)

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Nov 3, 2017 after 66 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: 2 generations back to K771645 (1977). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132253: Removable Patient Leads Ecg Cable, Boston Scientific (2013) Summary page 4.

## Indications for use
The Fixed 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 intended for use by trained operators in a medical environment. Usage is limited to the indications for use of the connected monitoring or diagnostic equipment.

Source page: https://510kreport.com/device/K172591
Methodology: https://510kreport.com/methodology