# K070232: Ecg Cables, Trunk and Patient Lead Wires

- Pathway: 510(k) (Abbreviated)
- Applicant: American I.V. Products, Inc.
- Decided: Mar 27, 2007 after 62 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 K920790 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945034: Conmed Ecg Patient Safety Cables and Leadwires-Removal and Permanently-Attached Leadwires, Conmedcorp (1994) Summary page 1.
- K933649: Conmed Ecg Patient Cables and Leadwires, Conmedcorp (1994) Summary page 1.
- K980582: Multi-Link Cable and Lead Wire Systems, Marquette Medical Systems, Inc. (1998) Summary page 1.
- K970545: Dash 1000 Patient Monitor, Marquette Medical Systems, Inc. (1997) Summary page 1.
- K964750: Eagle 4000 Patient Monitor, Marquette Electronics, Inc. (1997) Summary page 1.
- K960418: Eagle Patient Monitor, Marquette Electronics, Inc. (1996) Summary page 1.

## Indications for use
These devices are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. They are solely intended to be used between the disposable electrodes (not manufactured by AIV) in contact with the patient's skin and the recording/monitoring device (not manufactured by AIV). These cables are used by qualified personnel in the field of Cardiology for diagnostic and monitoring purposes. AIV cables are limited by the Indications for Use of the connected recording/monitoring device. No other usage is intended for the trunk cables or leadwires.

Source page: https://510kreport.com/device/K070232
Methodology: https://510kreport.com/methodology