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FDA 510(k)

PROSTHETIC RINGS #4400 MITRAL & 4500

K-Number: K831949 · 1983-07-29

ApplicantAmerican Edwards Laboratories
Decision Date1983-07-29
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking & PMS

Device Summary

PROSTHETIC RINGS #4400 MITRAL & 4500 is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1983-07-29 under 510(k) number K831949. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking & PMS.

Frequently Asked Questions

What is the PROSTHETIC RINGS #4400 MITRAL & 4500?

PROSTHETIC RINGS #4400 MITRAL & 4500 is a medical device that received FDA 510(k) clearance on 1983-07-29. The listed applicant is American Edwards Laboratories. The 510(k) number is K831949.

When did PROSTHETIC RINGS #4400 MITRAL & 4500 receive FDA 510(k) clearance?

PROSTHETIC RINGS #4400 MITRAL & 4500 received FDA 510(k) clearance on 1983-07-29, under 510(k) number K831949.

Who is the listed applicant for PROSTHETIC RINGS #4400 MITRAL & 4500?

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

What is the FDA product code for PROSTHETIC RINGS #4400 MITRAL & 4500?

The FDA product code for PROSTHETIC RINGS #4400 MITRAL & 4500 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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