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FDA 510(k)

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool

K-Number: K192996 · 2019-11-21

ApplicantBiotronik, Inc.
Decision Date2019-11-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2019-11-21 under approval 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. It is manufactured by Biotronik, Inc.. The 510(k) number is K192996.

When was Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool approved by the FDA?

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

What company makes Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool?

Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool is manufactured by Biotronik, Inc..

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.

Related Clinical Trials

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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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