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)

510(k) number: K241224
Device name: 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)
Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren OR · US
Product code: NLH — Catheter, Recording, Electrode, Reprocessed
Decision date: 2024-11-15
Date received: 2024-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K241224.pdf

Official FDA record: K241224

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.