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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K010253
Device Name ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101
Applicant
Transonic Systems, Inc.
34 Dutch Mill Rd.
Ithaca,  NY  14850
Applicant Contact MARK S ALSBERGE
Correspondent
Transonic Systems, Inc.
34 Dutch Mill Rd.
Ithaca,  NY  14850
Correspondent Contact MARK S ALSBERGE
Regulation Number870.1240
Classification Product Code
DYG  
Date Received01/26/2001
Decision Date 03/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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