# K090120: Refstar Plus with Qwikpatch External Reference Patch, Model D-1210-03, Refstar Plus Cable, Model M-4700-106

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Mar 24, 2009 after 62 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: 2 generations back to K982415 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061468: Refstar External Reference Patch, Biosense Webster, Inc. (2006) Summary page 1.
- K982415: Cordis Webster Ref-Star External Reference Patch, Model # D-1210, Cordis Webster, Inc. (1998) Summary page 1.

## Indications for use
REFSTAR ® PLUS with QWIKPATCH ® External Reference Patch: The Biosense Webster REFSTAR® or REFSTAR® PLUS External Reference Patch is indicated for use with the Biosense Webster navigation catheters and the CARTO® and NOGA® Systems to provide a reference point for catheter tip location. REFSTAR® PLUS Cable: The REFSTAR® PLUS Cable provides a means to connect between a Biosense Webster electrophysiology REFSTAR® PLUS with QWIKPATCH® External Reference Patch and the Patient Interface Unit (PIU). This cable may be re-used.

Source page: https://510kreport.com/device/K090120
Methodology: https://510kreport.com/methodology