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FDA 510(k)

AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE

K-Number: K842481 · 1984-10-18

ApplicantAmerican Edwards Laboratories
Decision Date1984-10-18
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE 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 1984-10-18 under 510(k) number K842481. The device is classified under product code LYK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE?

AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE is a medical device that received FDA 510(k) clearance on 1984-10-18. The listed applicant is American Edwards Laboratories. The 510(k) number is K842481.

When did AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE receive FDA 510(k) clearance?

AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE received FDA 510(k) clearance on 1984-10-18, under 510(k) number K842481.

Who is the listed applicant for AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE?

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 AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE?

The FDA product code for AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE is LYK.

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Related Devices (Code: LYK)

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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