ANGIOMED INTRODUCING SETS

Pump, Blood, Cardiopulmonary Bypass, Roller Type

ANGIOMED U.S., INC.

The following data is part of a premarket notification filed by Angiomed U.s., Inc. with the FDA for Angiomed Introducing Sets.

Pre-market Notification Details

Device IDK874771
510k NumberK874771
Device Name:ANGIOMED INTRODUCING SETS
ClassificationPump, Blood, Cardiopulmonary Bypass, Roller Type
Applicant ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim,  CA  92807
ContactMichael Mccallum
CorrespondentMichael Mccallum
ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim,  CA  92807
Product CodeDWB  
CFR Regulation Number870.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-19
Decision Date1988-01-12

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