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FDA 510(k)

CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R

K-Number: K061127 · 2006-05-23

ApplicantMedtronic Vascular
Decision Date2006-05-23
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2006-05-23 under 510(k) number K061127. 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 CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R?

CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R is a medical device that received FDA 510(k) clearance on 2006-05-23. The listed applicant is Medtronic Vascular. The 510(k) number is K061127.

When did CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R receive FDA 510(k) clearance?

CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R received FDA 510(k) clearance on 2006-05-23, under 510(k) number K061127.

Who is the listed applicant for CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R?

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

What is the FDA product code for CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R?

The FDA product code for CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R 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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