TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

CARDIAC ASSIST, INC.

The following data is part of a premarket notification filed by Cardiac Assist, Inc. with the FDA for Tandemheart Transseptal Cannula Set-ef, Model 5140-6221.

Pre-market Notification Details

Device IDK052570
510k NumberK052570
Device Name:TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant CARDIAC ASSIST, INC. 240 ALPHA DR. Pittsburgh,  PA  15238
ContactTim Krauskopf
CorrespondentTim Krauskopf
CARDIAC ASSIST, INC. 240 ALPHA DR. Pittsburgh,  PA  15238
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-19
Decision Date2006-01-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814112020395 K052570 000
00814112020371 K052570 000
00814112020364 K052570 000
00814112020234 K052570 000
00814112020128 K052570 000
00814112020067 K052570 000
00814112020036 K052570 000

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