FDA 510(k)

CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER

K-Number: K003020 · 2001-05-11

Decision Date2001-05-11

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cd Leycom BV. It received FDA 510(k) clearance on 2001-05-11 under 510(k) number K003020. 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 FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER?

CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER is a medical device that received FDA 510(k) clearance on 2001-05-11. The listed applicant is Cd Leycom BV. The 510(k) number is K003020.

When did CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER receive FDA 510(k) clearance?

CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER received FDA 510(k) clearance on 2001-05-11, under 510(k) number K003020.

Who is the listed applicant for CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER?

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

What is the FDA product code for CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER?

The FDA product code for CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER is DQO.

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Other records listing Cd Leycom BV as applicant

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Official Source

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