Cleared Abbreviated

QUINTON Q-CATH, MODEL 000460

K021906 · Quinton, Inc. · Cardiovascular
Sep 2002
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K021906 is an FDA 510(k) clearance for the QUINTON Q-CATH, MODEL 000460, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on September 4, 2002, 86 days after receiving the submission on June 10, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K021906 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2002
Decision Date September 04, 2002
Days to Decision 86 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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