# K061463: Esophageal Mapping Catheter, Model D-1272-01-S

- Pathway: 510(k) (Traditional)
- 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 K833621 (1983). 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)
- K954390: Cordis Wester Star Catheter, Cordis Webster, Inc. (1995) Summary page 1.
- K833621: Entri Flex Feeding Tube, Biosearch Medical Products, Inc. (1983) Summary page 1.

## Indications for use
The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter and related accessory devices are indicated for catheter-based anatomic mapping of the esophagus. When used during an electrophysiology ablation procedure, the EsophaStar is intended to be used in addition to other tools and techniques used to assist the physician in obtaining generalized location information of the esophagus with respect to the heart. The device is not intended to provide absolute esophageal wall location information. The Biosense Webster ESOPHASTAR™ Esophageal Mapping Catheter is placed in the esophagus via the transpharyngeal or transnasal approach.

Source page: https://510kreport.com/device/K061463
Methodology: https://510kreport.com/methodology