Selectra Catheters, Selectra Accessory Kit
K-Number: K183265 · 2018-12-13
ApplicantBiotronik, Inc.
Decision Date2018-12-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Selectra Catheters, Selectra Accessory Kit is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2018-12-13 under approval 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. It is manufactured by Biotronik, Inc.. The 510(k) number is K183265.
When was Selectra Catheters, Selectra Accessory Kit approved by the FDA?
Selectra Catheters, Selectra Accessory Kit received FDA 510(k) clearance on 2018-12-13, under approval number K183265.
What company makes Selectra Catheters, Selectra Accessory Kit?
Selectra Catheters, Selectra Accessory Kit is manufactured by Biotronik, Inc..
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.