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, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401
FDA 510(k) clearance K241156 · decided 2024-09-14
Clearance details
- K-number
- K241156
- Device name
- 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, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-26
- Decision date
- 2024-09-14
- Days to decision
- 141 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 Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Ju recall (Z-2615-2026) | Medline Industries, LP | 2026-07-02 |
| Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude recall (Z-1322-2026) | Medline Industries, LP | 2026-02-06 |
| Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysio recall (Z-2460-2025) | MEDLINE INDUSTRIES, LP - Northfield | 2025-08-28 |