FDA 510(k)

ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS

K-Number: K895495 · 1989-09-26

Decision Date1989-09-26

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1989-09-26 under 510(k) number K895495. 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 ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS?

ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS is a medical device that received FDA 510(k) clearance on 1989-09-26. The listed applicant is Medtronic Vascular. The 510(k) number is K895495.

When did ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS receive FDA 510(k) clearance?

ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS received FDA 510(k) clearance on 1989-09-26, under 510(k) number K895495.

Who is the listed applicant for ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS?

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 ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS?

The FDA product code for ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS is DXY. This falls under the Clinical Chemistry category.

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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.