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FDA 510(k)

Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)

K-Number: K240787 · 2024-09-12

ApplicantBiotronik, Inc.
Decision Date2024-09-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2024-09-12 under approval number K240787. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)?

Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) is a medical device that received FDA 510(k) clearance on 2024-09-12. It is manufactured by Biotronik, Inc.. The 510(k) number is K240787.

When was Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) approved by the FDA?

Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) received FDA 510(k) clearance on 2024-09-12, under approval number K240787.

What company makes Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)?

Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) is manufactured by Biotronik, Inc..

What is the FDA product code for Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)?

The FDA product code for Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) is DQY.

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Other Devices by Biotronik, Inc.

K160985Pantera Pro K152995BioMonitor 2-AF, BioMonitor 2-S K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set K170628BioMonitor 2-AF, BioMonitor 2-S K163660Pantera LEO K183265Selectra Catheters, Selectra Accessory Kit

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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