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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2017-01-26 under 510(k) 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. The listed applicant is Biotronik, Inc.. The 510(k) number is K163660.

When did Pantera LEO receive FDA 510(k) clearance?

Pantera LEO received FDA 510(k) clearance on 2017-01-26, under 510(k) number K163660.

Who is the listed applicant for Pantera LEO?

The FDA 510(k) record lists Biotronik, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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