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FDA 510(k)

TAVIPILOT

K-Number: K243884 · 2025-07-07

ApplicantCaranx Medical
Decision Date2025-07-07
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TAVIPILOT is a medical device manufactured by Caranx Medical. It received FDA 510(k) clearance on 2025-07-07 under approval number K243884. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAVIPILOT?

TAVIPILOT is a medical device that received FDA 510(k) clearance on 2025-07-07. It is manufactured by Caranx Medical. The 510(k) number is K243884.

When was TAVIPILOT approved by the FDA?

TAVIPILOT received FDA 510(k) clearance on 2025-07-07, under approval number K243884.

What company makes TAVIPILOT?

TAVIPILOT is manufactured by Caranx Medical.

What is the FDA product code for TAVIPILOT?

The FDA product code for TAVIPILOT is OWB.

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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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