# K093858: Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
- Decided: Apr 2, 2010 after 107 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 P910023 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P910023: Cadence (R) Tiered Therapy Defibrillation System, Abbott Medical (1993) Summary page 1.
- P030054: ST Jude Medical Epic HF System, Abbott Medical (2004) Summary page 1.
- P950022: TVL (TM) Lead System, Abbott Medical (1996) Summary page 1.
- K971968: Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97), Remington Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K101982: Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180 (2010), 0 descendants of its own

## Indications for use
The Model 4160 PSA disposable threshold cable is intended to connect IS- I or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field. The Model 4161 PSA disposable threshold cable is intended to connect IS- I or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing device such as a PSA (Pacing System Analyzer) located outside the sterile field. The Model 4053A non-disposable PSA cable adapter is intended to be used with the St. Jude Medical Model 4051 and 405 1 A cables to connect a cardiac pacing lead to the SJM Model 3150 PSA or Biotronik model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

Source page: https://510kreport.com/device/K093858
Methodology: https://510kreport.com/methodology