FDA 510(k)

CARDIAC CATHERIZATION KIT

K-Number: K914299 · 1992-06-03

Decision Date1992-06-03

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARDIAC CATHERIZATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1992-06-03 under 510(k) number K914299. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC CATHERIZATION KIT?

CARDIAC CATHERIZATION KIT is a medical device that received FDA 510(k) clearance on 1992-06-03. The listed applicant is Abbott Laboratories. The 510(k) number is K914299.

When did CARDIAC CATHERIZATION KIT receive FDA 510(k) clearance?

CARDIAC CATHERIZATION KIT received FDA 510(k) clearance on 1992-06-03, under 510(k) number K914299.

Who is the listed applicant for CARDIAC CATHERIZATION KIT?

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

What is the FDA product code for CARDIAC CATHERIZATION KIT?

The FDA product code for CARDIAC CATHERIZATION KIT is DQO.

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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.