Pantera LEO
K-Number: K163660 · 2017-01-26
ApplicantBiotronik, Inc.
Decision Date2017-01-26
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Pantera LEO is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2017-01-26 under approval number K163660. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pantera LEO?
Pantera LEO is a medical device that received FDA 510(k) clearance on 2017-01-26. It is manufactured by Biotronik, Inc.. The 510(k) number is K163660.
When was Pantera LEO approved by the FDA?
Pantera LEO received FDA 510(k) clearance on 2017-01-26, under approval number K163660.
What company makes Pantera LEO?
Pantera LEO is manufactured by Biotronik, Inc..
What is the FDA product code for Pantera LEO?
The FDA product code for Pantera LEO is LOX.
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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.