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FDA 510(k)

MEMO 3D SEMIRIGID ANNULOPLASTY RING

K-Number: K071327 · 2007-08-10

ApplicantSorin Biomedica Cardio S.R.L.
Decision Date2007-08-10
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEMO 3D SEMIRIGID ANNULOPLASTY RING is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica Cardio S.R.L.. It received FDA 510(k) clearance on 2007-08-10 under 510(k) number K071327. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEMO 3D SEMIRIGID ANNULOPLASTY RING?

MEMO 3D SEMIRIGID ANNULOPLASTY RING is a medical device that received FDA 510(k) clearance on 2007-08-10. The listed applicant is Sorin Biomedica Cardio S.R.L.. The 510(k) number is K071327.

When did MEMO 3D SEMIRIGID ANNULOPLASTY RING receive FDA 510(k) clearance?

MEMO 3D SEMIRIGID ANNULOPLASTY RING received FDA 510(k) clearance on 2007-08-10, under 510(k) number K071327.

Who is the listed applicant for MEMO 3D SEMIRIGID ANNULOPLASTY RING?

The FDA 510(k) record lists Sorin Biomedica Cardio S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEMO 3D SEMIRIGID ANNULOPLASTY RING?

The FDA product code for MEMO 3D SEMIRIGID ANNULOPLASTY RING is KRH.

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Related Devices (Code: KRH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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