# K100254: Reprocessed CS BI-Diectional Diagnostic Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ascent Healthcare Solutions
- Decided: May 28, 2010 after 120 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 27 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K050877 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050877: Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR, Biosense Webster, Inc. (2005) Summary page 1.

## Most influential descendants
- K181056: Reprocessed CS Diagnostic Electrophysiology Catheter (2019), 0 descendants of its own

## Recalls of this device
- Apr 10, 2026 · Class II · Z-2192-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2196-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2189-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2191-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2185-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2182-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2198-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2195-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2193-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2194-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2183-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2197-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2177-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2186-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2187-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2176-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2175-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2178-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2179-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2181-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2199-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2184-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2180-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2174-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2190-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2188-2026: Incomplete seals on sterile product
- Mar 29, 2018 · Class II · Z-2426-2018: Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .

## Indications for use
The Reprocessed CS Bi-Directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Source page: https://510kreport.com/device/K100254
Methodology: https://510kreport.com/methodology