Surgical Instrument Service and Savings, Inc. · Class II · Cleared Sep 14, 2024
| 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. |
| Product code | NLH |
| Device class | Class II |
| Decision date | Sep 14, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 870.1220 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov