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FDA 510(k)

MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R

K-Number: K073324 · 2008-03-13

ApplicantMedtronic, Inc.
Decision Date2008-03-13
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2008-03-13 under 510(k) number K073324. 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 PROFILE 3D ANNULOPLASTY RING, MODEL 680R?

MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R is a medical device that received FDA 510(k) clearance on 2008-03-13. The listed applicant is Medtronic, Inc.. The 510(k) number is K073324.

When did MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R receive FDA 510(k) clearance?

MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R received FDA 510(k) clearance on 2008-03-13, under 510(k) number K073324.

Who is the listed applicant for MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R?

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 PROFILE 3D ANNULOPLASTY RING, MODEL 680R?

The FDA product code for MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R 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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