FOCUS BALLOON DILATATION CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

CARDIOVASCULAR DYNAMICS, INC.

The following data is part of a premarket notification filed by Cardiovascular Dynamics, Inc. with the FDA for Focus Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK944016
510k NumberK944016
Device Name:FOCUS BALLOON DILATATION CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant CARDIOVASCULAR DYNAMICS, INC. 13844 ALTON PKWY. SUITE 140 Irvine,  CA  92718
ContactMichael Crocker
CorrespondentMichael Crocker
CARDIOVASCULAR DYNAMICS, INC. 13844 ALTON PKWY. SUITE 140 Irvine,  CA  92718
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-16
Decision Date1994-12-20

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