Selectra 3D Outer Guiding Catheters
K-Number: K193474 · 2020-10-16
ApplicantBiotronik, Inc.
Decision Date2020-10-16
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Selectra 3D Outer Guiding Catheters is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2020-10-16 under approval number K193474. 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 3D Outer Guiding Catheters?
Selectra 3D Outer Guiding Catheters is a medical device that received FDA 510(k) clearance on 2020-10-16. It is manufactured by Biotronik, Inc.. The 510(k) number is K193474.
When was Selectra 3D Outer Guiding Catheters approved by the FDA?
Selectra 3D Outer Guiding Catheters received FDA 510(k) clearance on 2020-10-16, under approval number K193474.
What company makes Selectra 3D Outer Guiding Catheters?
Selectra 3D Outer Guiding Catheters is manufactured by Biotronik, Inc..
What is the FDA product code for Selectra 3D Outer Guiding Catheters?
The FDA product code for Selectra 3D Outer Guiding Catheters is DQY.
Related Clinical Trials
Other Devices by Biotronik, Inc.
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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.