# K091370: Radia Steerable Diagnostic Catheter

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 5, 2009 after 28 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 K992373 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992373: Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension Cable, C.R. Bard, Inc. (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K921872: EP*XT Steerable Electrode Catheter (previously known as Bard Steerable 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 1.

## Indications for use
Bard Electrophysiology's steerable diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

Source page: https://510kreport.com/device/K091370
Methodology: https://510kreport.com/methodology