Submission Details
| 510(k) Number | K222037 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 11, 2022 |
| Decision Date | July 19, 2022 |
| Days to Decision | 8 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Selectra Lead Implantation System
Jul 2022
Decision
8d
Days
Class 2
Risk
About This 510(k) Submission
K222037 is an FDA 510(k) clearance for the Selectra Lead Implantation System, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on July 19, 2022, 8 days after receiving the submission on July 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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