Pantera Pro
K-Number: K160985 · 2016-10-07
ApplicantBiotronik, Inc.
Decision Date2016-10-07
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Pantera Pro is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2016-10-07 under approval number K160985. 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 Pro is a medical device that received FDA 510(k) clearance on 2016-10-07. It is manufactured by Biotronik, Inc.. The 510(k) number is K160985.
When was Pantera Pro approved by the FDA?
Pantera Pro received FDA 510(k) clearance on 2016-10-07, under approval number K160985.
What company makes Pantera Pro?
Pantera Pro is manufactured by Biotronik, Inc..
What is the FDA product code for Pantera Pro?
The FDA product code for Pantera Pro 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.