Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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.
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact