# K052083: Navistar RMT Steerable Tip Diagnostic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Sep 29, 2005 after 58 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 K954390 (1995). 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)
- K954390: Cordis Wester Star Catheter, Cordis Webster, Inc. (1995) Summary page 1.

## Indications for use
The NAVISTARTM RMT Steerable Tip Diagnostic Catheter and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older. This catheter is only compatible with the Stereotaxis Magnetic Navigation Systems (MNS). When used with the CARTO TM RMT EP Navigation System, the NAVISTARTM RMT Steerable Tip Diagnostic Catheter provides location information.

Source page: https://510kreport.com/device/K052083
Methodology: https://510kreport.com/methodology