510(k) K241156 ยท NLH Catheter, Recording, Electrode, Reprocessed
Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 40135
| Applicant | Surgical Instrument Service and Savings, Inc., Redmond OR, US |
| Decision | Substantially Equivalent, Sep 14, 2024 |
| Received | Apr 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241156
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Medline Industries, LP Reprocessed Electrophysiology Catheters and Ultrasound Catheters
Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm;
Item no. 401305RH, St. Jude Medical Open, Classified |
NLH | None listed |
| Feb 6, 2026 | Medline Industries, LP Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters:
St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm
401211RH
401222RH
401223RH
401226RH
40 Open, Classified |
NLH | None listed |
| Aug 28, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models
401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, Open, Classified |
NLH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.