40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER

System, Balloon, Intra-aortic And Control

ARIES MEDICAL, INC.

The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for 40cc Percutaneous Pre-furl (d/l) Balloon Catheter.

Pre-market Notification Details

Device IDK864537
510k NumberK864537
Device Name:40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER
ClassificationSystem, Balloon, Intra-aortic And Control
Applicant ARIES MEDICAL, INC. TWO GILL ST. Woburn,  MA  01801
ContactBarry Asher
CorrespondentBarry Asher
ARIES MEDICAL, INC. TWO GILL ST. Woburn,  MA  01801
Product CodeDSP  
CFR Regulation Number870.3535 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-17
Decision Date1987-06-19

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