CARDIO METRIC CUSTOM PERFUSION TUBING

Tubing, Pump, Cardiopulmonary Bypass

STERILE DESIGN, INC.

The following data is part of a premarket notification filed by Sterile Design, Inc. with the FDA for Cardio Metric Custom Perfusion Tubing.

Pre-market Notification Details

Device IDK841959
510k NumberK841959
Device Name:CARDIO METRIC CUSTOM PERFUSION TUBING
ClassificationTubing, Pump, Cardiopulmonary Bypass
Applicant STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar,  FL  34677 -0137
ContactJohn C Hoffman
CorrespondentJohn C Hoffman
STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar,  FL  34677 -0137
Product CodeDWE  
CFR Regulation Number870.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-14
Decision Date1984-10-19

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