Pantera Pro; Pantera LEO
K-Number: K242969 · 2024-10-25
ApplicantBiotronik, Inc.
Decision Date2024-10-25
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Pantera Pro; Pantera LEO is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2024-10-25 under approval number K242969. 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 Pro; Pantera LEO?
Pantera Pro; Pantera LEO is a medical device that received FDA 510(k) clearance on 2024-10-25. It is manufactured by Biotronik, Inc.. The 510(k) number is K242969.
When was Pantera Pro; Pantera LEO approved by the FDA?
Pantera Pro; Pantera LEO received FDA 510(k) clearance on 2024-10-25, under approval number K242969.
What company makes Pantera Pro; Pantera LEO?
Pantera Pro; Pantera LEO is manufactured by Biotronik, Inc..
What is the FDA product code for Pantera Pro; Pantera LEO?
The FDA product code for Pantera Pro; 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.