# K101982: Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical, Crmd
- Decided: Dec 21, 2010 after 160 days
- Product code: DTA (Tester, Pacemaker Electrode Function)
- Device class: 2
- Regulation: 21 CFR 870.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K883930 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022360: Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000 Battery (Type 2); NK-11 Power Supp., Biotronik, Inc. (2003) Summary page 1.
- K093858: Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A, St. Jude Medical, Cardiac Rhythm Management Divisi (2010) Summary page 1.

## Indications for use
The Merlin PSA Patient Cable EX3 150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-I leads or to SJ4 leads. The Merlin PSA Patient Cable Adapter EX3 170 is a three-channel adapter intended to connect the Merlin PSA to as many as three disposable patient cables. The EX3 170 Cable Adapter can connect to the Models 4051/4051IA disposable patient cables for IS-i leads or to the Model 4161 disposable patient cable for SJ4 leads. The opposite ends of the disposable patient cables connect to implantable pacing leads. The Merlin PSA "M" Adapter Model EX3 180 is intended to connect the Merlin PSA to the two-channel Medtronic Model 2292 re-sterilizable patient cable. The opposite end of the Medtronic Model 2292 cable connects to implantable pacing leads. Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.

Source page: https://510kreport.com/device/K101982
Methodology: https://510kreport.com/methodology