Cleared Traditional

POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS

K080637 · Stereotaxis, Inc. · Cardiovascular
Aug 2008
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K080637 is an FDA 510(k) clearance for the POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 12, 2008, 159 days after receiving the submission on March 6, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K080637 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2008
Decision Date August 12, 2008
Days to Decision 159 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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