FDA 510(k)

Selectra Lead Implantation System

K-Number: K222037 · 2022-07-19

Decision Date2022-07-19

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Selectra Lead Implantation System is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2022-07-19 under 510(k) 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. The listed applicant is Biotronik, Inc.. The 510(k) number is K222037.

When did Selectra Lead Implantation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Selectra Lead Implantation System?

The FDA 510(k) record lists Biotronik, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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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.