DESCENDING ARCH CANNULA

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 Descending Arch Cannula.

Pre-market Notification Details

Device IDK880421
510k NumberK880421
Device Name:DESCENDING ARCH CANNULA
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
ContactVan Hof
CorrespondentVan Hof
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 Received1988-02-01
Decision Date1988-04-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.