FDA 510(k)

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool

K-Number: K192996 · 2019-11-21

Decision Date2019-11-21

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K192996. 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 Catheters, Selectra Accessory Kit, Selectra Slitter Tool?

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Biotronik, Inc.. The 510(k) number is K192996.

When did Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool receive FDA 510(k) clearance?

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool received FDA 510(k) clearance on 2019-11-21, under 510(k) number K192996.

Who is the listed applicant for Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool?

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 Catheters, Selectra Accessory Kit, Selectra Slitter Tool?

The FDA product code for Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool 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.