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FDA 510(k)

CARDIOSLEEVE

K-Number: K131287 · 2013-06-24

ApplicantRijuven Corp
Decision Date2013-06-24
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Rijuven Corp. It received FDA 510(k) clearance on 2013-06-24 under 510(k) number K131287. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOSLEEVE?

CARDIOSLEEVE is a medical device that received FDA 510(k) clearance on 2013-06-24. The listed applicant is Rijuven Corp. The 510(k) number is K131287.

When did CARDIOSLEEVE receive FDA 510(k) clearance?

CARDIOSLEEVE received FDA 510(k) clearance on 2013-06-24, under 510(k) number K131287.

Who is the listed applicant for CARDIOSLEEVE?

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

What is the FDA product code for CARDIOSLEEVE?

The FDA product code for CARDIOSLEEVE is DQD.

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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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