FDA 510(k)

MEDTRONIC CLASSIX MODELS 8436/8437/8438

K-Number: K871866 · 1987-08-10

Decision Date1987-08-10

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC CLASSIX MODELS 8436/8437/8438 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1987-08-10 under 510(k) number K871866. 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 CLASSIX MODELS 8436/8437/8438?

MEDTRONIC CLASSIX MODELS 8436/8437/8438 is a medical device that received FDA 510(k) clearance on 1987-08-10. The listed applicant is Medtronic Vascular. The 510(k) number is K871866.

When did MEDTRONIC CLASSIX MODELS 8436/8437/8438 receive FDA 510(k) clearance?

MEDTRONIC CLASSIX MODELS 8436/8437/8438 received FDA 510(k) clearance on 1987-08-10, under 510(k) number K871866.

Who is the listed applicant for MEDTRONIC CLASSIX MODELS 8436/8437/8438?

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 CLASSIX MODELS 8436/8437/8438?

The FDA product code for MEDTRONIC CLASSIX MODELS 8436/8437/8438 is DXY. This falls under the Clinical Chemistry category.

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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.