Submission Details
| 510(k) Number | K223178 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 11, 2022 |
| Decision Date | November 08, 2022 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
SelectSite C304 Deflectable Catheter System, C315 Delivery System
Nov 2022
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K223178 is an FDA 510(k) clearance for the SelectSite C304 Deflectable Catheter System, C315 Delivery System, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on November 8, 2022, 28 days after receiving the submission on October 11, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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