MEDRAD HIGH PRESSURE CONECTING TUBE

Tubing, Pump, Cardiopulmonary Bypass

MEDRAD, INC.

The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad High Pressure Conecting Tube.

Pre-market Notification Details

Device IDK810924
510k NumberK810924
Device Name:MEDRAD HIGH PRESSURE CONECTING TUBE
ClassificationTubing, Pump, Cardiopulmonary Bypass
Applicant MEDRAD, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDWE  
CFR Regulation Number870.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-06
Decision Date1981-04-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40616258008538 K810924 000
40616258008521 K810924 000
40616258008514 K810924 000
40616258008507 K810924 000
60616258021531 K810924 000

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