# K112292: Reprocessed 2515 Nav Variable Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions
- Decided: Oct 21, 2011 after 72 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002333 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081258: Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02, Biosense Webster, Inc. (2009) Summary page 1.
- K082023: Reprocessed Electrophysiology Catheters, Ascent Healthcare Solutions (2008) Summary page 1.
- K031161: Variable Lasso 2515 Circular Mapping Catheter, Biosense Webster, Inc. (2003) Summary page 1.

## Recalls of this device
- May 10, 2024 · Class II · Z-2268-2024: Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
- Dec 17, 2018 · Class II · Z-0766-2019: Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) 
- Aug 23, 2018 · Class II · Z-0467-2019: Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
- Jan 2, 2018 · Class II · Z-0916-2018: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
- Jan 2, 2018 · Class II · Z-0917-2018: An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.

## Indications for use
The Reprocessed 2515 NAV Variable EP Catheter are indicated for multiple electrode electrophysiology mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Reprocessed 2515 NAV Variable EP Catheter are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV Variable EP Catheter provides location information when used with compatible CARTO® EP Navigation Systems version 1.0 or higher.

Source page: https://510kreport.com/device/K112292
Methodology: https://510kreport.com/methodology