INTRACARDIAC SUMP 12010

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 Intracardiac Sump 12010.

Pre-market Notification Details

Device IDK850385
510k NumberK850385
Device Name:INTRACARDIAC SUMP 12010
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 Received1985-02-01
Decision Date1985-04-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994619277 K850385 000
20613994619260 K850385 000
20613994619246 K850385 000
20613994619239 K850385 000
20613994619215 K850385 000

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