# K992373: Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension Cable

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 5, 1999 after 113 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
No predicates in its family tree.
3 later devices descend from it; 3 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Viking Diagnostic Electrode Catheter: named in the summary without a submission number
- (no number) Bard EPeXT Electrode Catheter: named in the summary without a submission number
- (no number) Bard Woven Electrode Catheter: named in the summary without a submission number
- (no number) Cordis Webster Electrophysiology Catheter: named in the summary without a submission number

## Most influential descendants
- K161393: Reprocessed Orbiter ST Steerable Diagnostic EP Catheter (2016), 0 descendants of its own
- K091370: Radia Steerable Diagnostic Catheter (2009), 0 descendants of its own
- K030187: Reprocessed Electrophysiology Catheter (2003), 0 descendants of its own

## 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. The Orbiter ST extension cable is indicated for use during electrophysiology studies in conjunction with the appropriate electrode catheter. This cable may be reused subject to the cleaning and sterilization restrictions herein.

Source page: https://510kreport.com/device/K992373
Methodology: https://510kreport.com/methodology