PICSO CANNULA, CATALOG CODE 94315

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Picso Cannula, Catalog Code 94315.

Pre-market Notification Details

Device IDK897022
510k NumberK897022
Device Name:PICSO CANNULA, CATALOG CODE 94315
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
ContactChet Vanhof
CorrespondentChet Vanhof
DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-19
Decision Date1990-03-16

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