Cleared Special

ACUITY UNIVERSAL CUTTER

K080154 · Cardiac Pacemakers, Inc. · Cardiovascular
Mar 2008
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K080154 is an FDA 510(k) clearance for the ACUITY UNIVERSAL CUTTER, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 20, 2008, 57 days after receiving the submission on January 23, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K080154 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2008
Decision Date March 20, 2008
Days to Decision 57 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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