Cleared Traditional

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

K010253 · Transonic Systems, Inc. · Cardiovascular
Mar 2002
Decision
417d
Days
Class 2
Risk

About This 510(k) Submission

K010253 is an FDA 510(k) clearance for the ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101, a Catheter, Flow Directed (Class II — Special Controls, product code DYG), submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on March 19, 2002, 417 days after receiving the submission on January 26, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1240.

Submission Details

510(k) Number K010253 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2001
Decision Date March 19, 2002
Days to Decision 417 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYG — Catheter, Flow Directed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1240

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