Selectra 3D Lead Delivery System (443624-443629, 451789-451791) +2 more— 510(k) K240787

Name: FDA 510(k) clearance K240787
Creator: U.S. Food and Drug Administration
Published: 2024-09-12

Substantially Equivalent

Biotronik, Inc.

FDA 510(k) clearance K240787 for Selectra 3D Lead Delivery System (443624-443629, 451789-451791) +2 more, Substantially Equivalent on 2024-09-12. Applicant: Biotronik, Inc.. Device class: 2.

Clearance details

Device name as filed: Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)
Applicant: Biotronik, Inc.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2024-03-22
Decision date: 2024-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.