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FDA 510(k)

Selectra Lead Implantation System

K-Number: K222037 · 2022-07-19

ApplicantBiotronik, Inc.
Decision Date2022-07-19
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Selectra Lead Implantation System is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2022-07-19 under approval number K222037. 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 Lead Implantation System?

Selectra Lead Implantation System is a medical device that received FDA 510(k) clearance on 2022-07-19. It is manufactured by Biotronik, Inc.. The 510(k) number is K222037.

When was Selectra Lead Implantation System approved by the FDA?

Selectra Lead Implantation System received FDA 510(k) clearance on 2022-07-19, under approval number K222037.

What company makes Selectra Lead Implantation System?

Selectra Lead Implantation System is manufactured by Biotronik, Inc..

What is the FDA product code for Selectra Lead Implantation System?

The FDA product code for Selectra Lead Implantation System is DQY.

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Other Devices by Biotronik, Inc.

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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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