# K042998: Refstar RMT External Reference Patch

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Sep 29, 2005 after 332 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 K980961 (1998). 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)
- K980961: Cordis Webster Ref-Star EX Surface Reference Device Model's D-1204-01, -02,-03, and -04., Cordis Webster, Inc. (1998) Summary page 1.

## Indications for use
The RefStar™ RMT External Reference Patch is indicated for use with the NAVI-STAR™ RMT catheter and the CARTO™ RMT system to provide catheter tip location as well as electrogram information.

Source page: https://510kreport.com/device/K042998
Methodology: https://510kreport.com/methodology