PUL,MONARY ARTERY VENT CATHETER

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 Pul,monary Artery Vent Catheter.

Pre-market Notification Details

Device IDK845046
510k NumberK845046
Device Name:PUL,MONARY ARTERY VENT CATHETER
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids,  MI  49501
ContactRonald A Williams
CorrespondentRonald A Williams
DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids,  MI  49501
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-28
Decision Date1985-04-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994742388 K845046 000

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