# K171503: Reprocessed CristaCath Diagnostic Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Oct 5, 2017 after 135 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- 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 K953768 (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)
- K953768: Cordis Webster A20 Diagnostic Deflectable Tip Catheter, Cordis Webster, Inc. (1995) Summary page 5.

## Indications for use
The Reprocessed Cristacath Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheter is designed to facilitate electrograms in the atrial regions of the heart.

Source page: https://510kreport.com/device/K171503
Methodology: https://510kreport.com/methodology