ACUITY UNIVERSAL CUTTER

Catheter, Percutaneous

CARDIAC PACEMAKERS, INC.

The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Acuity Universal Cutter.

Pre-market Notification Details

Device IDK080154
510k NumberK080154
Device Name:ACUITY UNIVERSAL CUTTER
ClassificationCatheter, Percutaneous
Applicant CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH St. Paul,  MN  55112 -5798
ContactKathleen Vittum
CorrespondentKathleen Vittum
CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH St. Paul,  MN  55112 -5798
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-23
Decision Date2008-03-20
Summary:summary

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