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FDA 510(k)

COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600

K-Number: K923367 · 1993-01-06

ApplicantBaxter Healthcare Corp
Decision Date1993-01-06
Product CodeKRH
Advisory CommitteeCV
DecisionUnknown

Device Summary

COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1993-01-06 under 510(k) number K923367. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600?

COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 is a medical device that received FDA 510(k) clearance on 1993-01-06. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K923367.

When did COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 receive FDA 510(k) clearance?

COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 received FDA 510(k) clearance on 1993-01-06, under 510(k) number K923367.

Who is the listed applicant for COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600?

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

What is the FDA product code for COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600?

The FDA product code for COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 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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