AORTIC ROOT CANNULA W/INTEGRAL PRESS

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 Aortic Root Cannula W/integral Press.

Pre-market Notification Details

Device IDK831591
510k NumberK831591
Device Name:AORTIC ROOT CANNULA W/INTEGRAL PRESS
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant DLP, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-17
Decision Date1983-06-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994918608 K831591 000
20613994918585 K831591 000
20613994900412 K831591 000
20613994540090 K831591 000
20613994495420 K831591 000

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