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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2016-10-07 under 510(k) 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. The listed applicant is Biotronik, Inc.. The 510(k) number is K160985.

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

Pantera Pro received FDA 510(k) clearance on 2016-10-07, under 510(k) number K160985.

Who is the listed applicant for Pantera Pro?

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 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.

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