FDA 510(k)

MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE

K-Number: K854214 · 1985-12-03

Decision Date1985-12-03

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1985-12-03 under 510(k) number K854214. 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 MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE?

MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE is a medical device that received FDA 510(k) clearance on 1985-12-03. The listed applicant is Cordis Corp.. The 510(k) number is K854214.

When did MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE receive FDA 510(k) clearance?

MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE received FDA 510(k) clearance on 1985-12-03, under 510(k) number K854214.

Who is the listed applicant for MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE?

The FDA 510(k) record lists Cordis Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE?

The FDA product code for MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE 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.