AORTIC ROOT 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 Aortic Root Cannula.

Pre-market Notification Details

Device IDK790565
510k NumberK790565
Device Name:AORTIC ROOT CANNULA
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 Received1979-03-19
Decision Date1979-06-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169695955 K790565 000
20613994540182 K790565 000
20613994540168 K790565 000
20613994540151 K790565 000
20613994540144 K790565 000
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20613994540199 K790565 000
20613994540212 K790565 000
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00673978861418 K790565 000
20613994676140 K790565 000
20613994676126 K790565 000
20613994540267 K790565 000
20613994540250 K790565 000
20613994540236 K790565 000
00763000192389 K790565 000

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