ARTERIALFLOW SYSTEM, MODEL 32A

Sleeve, Limb, Compressible

AIRCAST, INC.

The following data is part of a premarket notification filed by Aircast, Inc. with the FDA for Arterialflow System, Model 32a.

Pre-market Notification Details

Device IDK024019
510k NumberK024019
Device Name:ARTERIALFLOW SYSTEM, MODEL 32A
ClassificationSleeve, Limb, Compressible
Applicant AIRCAST, INC. 92 RIVER RD. Summit,  NJ  07902
ContactStephen L Kenney
CorrespondentStephen L Kenney
AIRCAST, INC. 92 RIVER RD. Summit,  NJ  07902
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-05
Decision Date2003-06-03

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