# K955847: Gyro Tip EP Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Assist Devices, Inc.
- Decided: Jan 29, 1997 after 400 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 K891908 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891908: Bard (R) Tip Deflecting Electrode Catheter, C.R. Bard, Inc. (1989) Summary page 2.
- K900765: Steerocath (TM), Ep Technologies, Inc. (1990) Summary page 2.

## Cited in the summary but kept off the family tree
- K912213: Bard Dynamic Tip Catheter. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.
- K904080: Bard Tip Deflecting Catheter. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K012520: Gyro-Tip Lariat Deflectable Loop Mapping Catheter, Model GTL-20E (2002), 0 descendants of its own

## Indications for use
Monitor and record intra-cardiac electrical activities

Source page: https://510kreport.com/device/K955847
Methodology: https://510kreport.com/methodology