K241156
- 510(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. OR · US
- Product code
- NLH — Catheter, Recording, Electrode, Reprocessed
- Decision date
- 2024-09-14
- Date received
- 2024-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K241156.pdf
Official FDA record: K241156
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.