INTERSEPT 1375 VENOUS RESERVOIR

Reservoir, Blood, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Intersept 1375 Venous Reservoir.

Pre-market Notification Details

Device IDK903632
510k NumberK903632
Device Name:INTERSEPT 1375 VENOUS RESERVOIR
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim,  CA  92807
ContactNorma L Lowe
CorrespondentNorma L Lowe
MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim,  CA  92807
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-10
Decision Date1990-12-17

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