ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO

Catheter, Angioplasty, Peripheral, Transluminal

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Advanced Cardiovascular Sys Low Profile Pta Balloo.

Pre-market Notification Details

Device IDK851854
510k NumberK851854
Device Name:ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
ContactMarianna F Breshini
CorrespondentMarianna F Breshini
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-26
Decision Date1985-08-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.