# K021421: Padtac Electrophysiology Recording Catheters, Junction Cable Connector & Cable

- Pathway: 510(k) (Traditional)
- Applicant: Tz Medical, Inc.
- Decided: Apr 18, 2003 after 350 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- 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 K946333 (1995). 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)
- K961924: Ibi-1100 Steerable Electrophysiology Catheter System, Irvine Biomedical, Inc. (1997) Summary page 1.
- K946333: Ibi-1000(TM) Electrophysiology Cathter, Irvine Biomedical, Inc. (1995) Summary page 1.

## Indications for use
The fixed PadTac electrophysiology mapping and recording catheters and PadTac cables are used for recording intracardiac electrogram (EGM) and for cardiac stimulation during diagnostic electrophysiology studies. The catheters will be used in the high right atrium, right ventricular apex and HIS bundle (recording only). The cables and box connect the catheter to the recording system.

Source page: https://510kreport.com/device/K021421
Methodology: https://510kreport.com/methodology