Cleared Special

ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002

K033424 · Transonic Systems, Inc. · Cardiovascular
Dec 2003
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K033424 is an FDA 510(k) clearance for the ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002, a Flowmeter, Blood, Cardiovascular (Class II — Special Controls, product code DPW), submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on December 11, 2003, 49 days after receiving the submission on October 23, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2100.

Submission Details

510(k) Number K033424 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2003
Decision Date December 11, 2003
Days to Decision 49 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPW — Flowmeter, Blood, Cardiovascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2100

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