FDA 510(k)

ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101

K-Number: K010253 · 2002-03-19

Decision Date2002-03-19

Product CodeDYG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 is the device name listed in this FDA 510(k) record. The listed applicant is Transonic Systems, Inc.. It received FDA 510(k) clearance on 2002-03-19 under 510(k) number K010253. 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 ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101?

ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 is a medical device that received FDA 510(k) clearance on 2002-03-19. The listed applicant is Transonic Systems, Inc.. The 510(k) number is K010253.

When did ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 receive FDA 510(k) clearance?

ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 received FDA 510(k) clearance on 2002-03-19, under 510(k) number K010253.

Who is the listed applicant for ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101?

The FDA 510(k) record lists Transonic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101?

The FDA product code for ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 is DYG.

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Other records listing Transonic Systems, Inc. as applicant

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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.