# K080621: Fastlock, Model PC175M01, PC175MCE, PC005R01

- Pathway: 510(k) (Traditional)
- Applicant: European Custom Manufacturing BV
- Decided: Apr 29, 2008 after 55 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 K022075 (2002). 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)
- K022075: Disposable Temporary Pacing Cable,Models CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-Qloc-5, Cp Medical (2002) Summary page 3.

## Most influential descendants
- K200674: AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector (2020), 0 descendants of its own

## Indications for use
Fastlock pacing wire extension cable with connectors is indicated for use as an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes.

Source page: https://510kreport.com/device/K080621
Methodology: https://510kreport.com/methodology