Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
FDA 510(k) clearance K221067 · decided 2023-05-31
Clearance details
- K-number
- K221067
- Device name
- Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-04-12
- Decision date
- 2023-05-31
- Days to decision
- 414 days
- Clearance type
- Traditional
- Product code
- NLH
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable recall (Z-1321-2026) | Medline Industries, LP | 2026-02-06 |
| Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 4 recall (Z-2610-2025) | Medline Industries, LP | 2025-09-26 |
| Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item N recall (Z-1460-2025) | MEDLINE INDUSTRIES, LP - Northfield | 2025-03-26 |