FDA 510(k)

Selectra Catheters, Selectra Accessory Kit

K-Number: K183265 · 2018-12-13

Decision Date2018-12-13

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Selectra Catheters, Selectra Accessory Kit is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K183265. 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 Catheters, Selectra Accessory Kit is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Biotronik, Inc.. The 510(k) number is K183265.

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

Selectra Catheters, Selectra Accessory Kit received FDA 510(k) clearance on 2018-12-13, under 510(k) number K183265.

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

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?

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