FDA 510(k)

CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM

K-Number: K993245 · 1999-10-28

Decision Date1999-10-28

Product CodeDYG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM is the device name listed in this FDA 510(k) record. The listed applicant is Alba Critical Care, Ltd.. It received FDA 510(k) clearance on 1999-10-28 under 510(k) number K993245. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM?

CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM is a medical device that received FDA 510(k) clearance on 1999-10-28. The listed applicant is Alba Critical Care, Ltd.. The 510(k) number is K993245.

When did CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM receive FDA 510(k) clearance?

CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM received FDA 510(k) clearance on 1999-10-28, under 510(k) number K993245.

Who is the listed applicant for CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM?

The FDA 510(k) record lists Alba Critical Care, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM?

The FDA product code for CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM is DYG.

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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.