FDA 510(k)

MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE

K-Number: K904941 · 1991-01-03

Decision Date1991-01-03

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Control Systems, Inc.. It received FDA 510(k) clearance on 1991-01-03 under 510(k) number K904941. 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 MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE?

MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE is a medical device that received FDA 510(k) clearance on 1991-01-03. The listed applicant is Cardiac Control Systems, Inc.. The 510(k) number is K904941.

When did MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE receive FDA 510(k) clearance?

MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE received FDA 510(k) clearance on 1991-01-03, under 510(k) number K904941.

Who is the listed applicant for MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE?

The FDA 510(k) record lists Cardiac Control Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE?

The FDA product code for MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE is DXY. This falls under the Clinical Chemistry category.

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Other records listing Cardiac Control Systems, Inc. as applicant

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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.