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FDA 510(k)

MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R

K-Number: K101212 · 2010-08-07

ApplicantMedtronic, Inc.
Decision Date2010-08-07
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2010-08-07 under 510(k) number K101212. 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 MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R?

MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R is a medical device that received FDA 510(k) clearance on 2010-08-07. The listed applicant is Medtronic, Inc.. The 510(k) number is K101212.

When did MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R receive FDA 510(k) clearance?

MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R received FDA 510(k) clearance on 2010-08-07, under 510(k) number K101212.

Who is the listed applicant for MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R?

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

What is the FDA product code for MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R?

The FDA product code for MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R is KRH.

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Related Devices (Code: KRH)

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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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