# K030627: Orbiter PV Diagnostic Electrode Catheter, Models 320100 & 320110

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 23, 2003 after 238 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 K971265 (1997). 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)
- K971265: Viking Diagnostic Electrode Catheter, C.R. Bard, Inc. (1997) Summary page 2.
- (no number) Orbiter ST Diagnostic Electrode Catheter: named in the summary without a submission number
- (no number) Bard Woven Electrode Catheter: named in the summary without a submission number

## 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/K030627
Methodology: https://510kreport.com/methodology