FDA 510(k)

STANICOR THETA MODEL 221 CARDIAC PACER

K-Number: K780453 · 1978-06-30

Decision Date1978-06-30

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

STANICOR THETA MODEL 221 CARDIAC PACER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1978-06-30 under 510(k) number K780453. 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 STANICOR THETA MODEL 221 CARDIAC PACER?

STANICOR THETA MODEL 221 CARDIAC PACER is a medical device that received FDA 510(k) clearance on 1978-06-30. The listed applicant is Cordis Corp.. The 510(k) number is K780453.

When did STANICOR THETA MODEL 221 CARDIAC PACER receive FDA 510(k) clearance?

STANICOR THETA MODEL 221 CARDIAC PACER received FDA 510(k) clearance on 1978-06-30, under 510(k) number K780453.

Who is the listed applicant for STANICOR THETA MODEL 221 CARDIAC PACER?

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 STANICOR THETA MODEL 221 CARDIAC PACER?

The FDA product code for STANICOR THETA MODEL 221 CARDIAC PACER 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.