# K241224: Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren
- Decided: Nov 15, 2024 after 197 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K983171 (1999). 20 ancestors in all.
No later device cites it as a predicate yet.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101345: Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer Technology and Auto ID Model: D-1263-04,, Biosense Webster, Inc. (2010) Summary page 6.
- K231312: PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID, Biosense Webster, Inc. (2023) Summary page 6.

## Recalls of this device
- Dec 22, 2025 · Class I · Z-1319-2026: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous react
- Jul 31, 2025 · Class I · Z-2611-2025: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is

## Indications for use
The Medline ReNewal Reprocessed Biosense Webster Webster CS 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/K241224
Methodology: https://510kreport.com/methodology