FDA 510(k)

BIPOLAR CARDIAC PACEMAKER, MODEL 110

K-Number: K861009 · 1986-04-23

Decision Date1986-04-23

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BIPOLAR CARDIAC PACEMAKER, MODEL 110 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 1986-04-23 under 510(k) number K861009. 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 BIPOLAR CARDIAC PACEMAKER, MODEL 110?

BIPOLAR CARDIAC PACEMAKER, MODEL 110 is a medical device that received FDA 510(k) clearance on 1986-04-23. The listed applicant is Cardiac Control Systems, Inc.. The 510(k) number is K861009.

When did BIPOLAR CARDIAC PACEMAKER, MODEL 110 receive FDA 510(k) clearance?

BIPOLAR CARDIAC PACEMAKER, MODEL 110 received FDA 510(k) clearance on 1986-04-23, under 510(k) number K861009.

Who is the listed applicant for BIPOLAR CARDIAC PACEMAKER, MODEL 110?

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 BIPOLAR CARDIAC PACEMAKER, MODEL 110?

The FDA product code for BIPOLAR CARDIAC PACEMAKER, MODEL 110 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.