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FDA 510(k)

INVISIPORT

K-Number: K110407 · 2011-10-13

ApplicantStealth Therapeutics, Incorporated
Decision Date2011-10-13
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INVISIPORT is the device name listed in this FDA 510(k) record. The listed applicant is Stealth Therapeutics, Incorporated. It received FDA 510(k) clearance on 2011-10-13 under 510(k) number K110407. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVISIPORT?

INVISIPORT is a medical device that received FDA 510(k) clearance on 2011-10-13. The listed applicant is Stealth Therapeutics, Incorporated. The 510(k) number is K110407.

When did INVISIPORT receive FDA 510(k) clearance?

INVISIPORT received FDA 510(k) clearance on 2011-10-13, under 510(k) number K110407.

Who is the listed applicant for INVISIPORT?

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

What is the FDA product code for INVISIPORT?

The FDA product code for INVISIPORT is LJT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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