FDA 510(k)

MEDTRONIC MODELS 59401 5941

K-Number: K823831 · 1983-03-16

Decision Date1983-03-16

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC MODELS 59401 5941 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1983-03-16 under 510(k) number K823831. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC MODELS 59401 5941?

MEDTRONIC MODELS 59401 5941 is a medical device that received FDA 510(k) clearance on 1983-03-16. The listed applicant is Medtronic Vascular. The 510(k) number is K823831.

When did MEDTRONIC MODELS 59401 5941 receive FDA 510(k) clearance?

MEDTRONIC MODELS 59401 5941 received FDA 510(k) clearance on 1983-03-16, under 510(k) number K823831.

Who is the listed applicant for MEDTRONIC MODELS 59401 5941?

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 MEDTRONIC MODELS 59401 5941?

The FDA product code for MEDTRONIC MODELS 59401 5941 is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.