510(k) K241224 ยท NLH Catheter, Recording, Electrode, Reprocessed
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, Redmond OR, US |
| Decision | Substantially Equivalent, Nov 15, 2024 |
| Received | May 2, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241224
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2026 | Medline Industries, LP Medline ReNewal Reprocessed Webster CS Catheters:
Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer
BD710DF282CRH;
Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer
Open, Classified |
NLH | None listed |
| Sep 26, 2025 | Medline Industries, LP Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH Open, Classified |
NLH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.