FDA 510(k) Applications Submitted by Lori DonDiego

FDA 510(k) Number Submission Date Device Name Applicant
K040740 03/22/2004 ENDOTINE TRANSBLEPH DEVICE COAPT SYSTEMS, INC.
K191557 06/12/2019 CentriMag Acute Circulatory Support System Thoratec Corporation (now part of Abbott)
K031882 06/18/2003 ENDOSCOPIC APPLICATOR BAXTER HEALTHCARE CORP.
K041835 07/07/2004 ENDOTINE MIDFACE B 4.5 DEVICE COAPT SYSTEMS, INC.
K042078 08/02/2004 ENDOTINE FOREHEAD TRIPLE DEVICE COAPT SYSTEMS, INC.
K152161 08/03/2015 Thoratec CentriMag Return (Arterial) Cannula Kit Thoratec Corporation
K152190 08/05/2015 Thoratec CentriMag Drainage (Venous) Cannula Kit THORATEC CORPORATION
K032698 09/02/2003 COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE COAPT SYSTEMS, INC.
K032770 09/08/2003 ENDOTINE FOREHEAD DEVICE COAPT SYSTEMS, INC.
K033524 11/07/2003 COAPT ENDOTINE CHIN 3.5 DEVICE COAPT SYSTEMS, INC.


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