510(k) K221067 ยท NLH Catheter, Recording, Electrode, Reprocessed
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
| Applicant | Surgical Instrument Service and Savings, Inc., Redmond OR, US |
| Decision | Substantially Equivalent, May 31, 2023 |
| Received | Apr 12, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221067
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2026 | Medline Industries, LP Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters:
Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm
401582RH
401940RH;
Livewire Steerable Electrophysiology Catheter Open, Classified |
NLH | None listed |
| Sep 26, 2025 | Medline Industries, LP Reprocessed Livewire Steerable Electrophysiology Catheter
Item Numbers 401575RH
401582RH
401600RH
401603RH
401606RH
401652RH
401653RH
401654RH
401904RH
401905RH
401908RH
401914RH
401915RH
401918RH
40 Open, Classified |
NLH | None listed |
| Mar 26, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R Open, Classified |
NLH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.