FDA 510(k)

XYREL-RA MODELS 5994/5995

K-Number: K771770 · 1978-01-04

Decision Date1978-01-04

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

XYREL-RA MODELS 5994/5995 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1978-01-04 under 510(k) number K771770. 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 XYREL-RA MODELS 5994/5995?

XYREL-RA MODELS 5994/5995 is a medical device that received FDA 510(k) clearance on 1978-01-04. The listed applicant is Medtronic Vascular. The 510(k) number is K771770.

When did XYREL-RA MODELS 5994/5995 receive FDA 510(k) clearance?

XYREL-RA MODELS 5994/5995 received FDA 510(k) clearance on 1978-01-04, under 510(k) number K771770.

Who is the listed applicant for XYREL-RA MODELS 5994/5995?

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 XYREL-RA MODELS 5994/5995?

The FDA product code for XYREL-RA MODELS 5994/5995 is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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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.