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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2024-10-25 under 510(k) 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. The listed applicant is Biotronik, Inc.. The 510(k) number is K242969.

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

Pantera Pro; Pantera LEO received FDA 510(k) clearance on 2024-10-25, under 510(k) number K242969.

Who is the listed applicant for Pantera Pro; 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 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.

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