# K061468: Refstar External Reference Patch

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Aug 14, 2006 after 80 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 K982415 (1998). 1 ancestor in all.
49 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K072202: Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches (Model:D-1283-01) (2007), 47 descendants of its own
- K090017: Carto 3 EP Navigation System, V1.0 and Accessories (2009), 45 descendants of its own
- K093455: Carto 3 Version 1.05 EP Navigation System and Accessories (2009), 34 descendants of its own
- K103746: Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation System,Version 2.0 W/RMT Pad) (2011), 33 descendants of its own
- K112007: Carto 3 EP Navigation System, Version 2.2 (2011), 32 descendants of its own

## Indications for use
The Biosense Webster RefStar External Reference Patch is indicated for use with Biosense Webster navigation catheters and the CARTO and NOGA Systems to provide a reference point for catheter tip location.

Source page: https://510kreport.com/device/K061468
Methodology: https://510kreport.com/methodology