Submission Details
| 510(k) Number | K240787 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 22, 2024 |
| Decision Date | September 12, 2024 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
Sep 2024
Decision
174d
Days
Class 2
Risk
About This 510(k) Submission
K240787 is an FDA 510(k) clearance for the Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518), a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on September 12, 2024, 174 days after receiving the submission on March 22, 2024. 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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