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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceQUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
Cardiva Medical, Inc.
2900 lakeside drive
suite 160
santa clara, CA 95054
PMA NumberP080029
Date Received12/05/2008
Decision Date04/08/2010
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 10M-0220
Notice Date 04/23/2010
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE QUICK-CLOSE VASCULAR SUTURING SYSTEM. THIS DEVICE IS INDICATED AS FOLLOWS:THE QUICK-CLOSE VASCULAR SUTURING SYSTEM IS INDICATED TO CLOSE FEMORAL ARTERY ACCESSSITES AND TO REDUCE TIME-TO-HEMOSTASIS AND TIME-TO-AMBULATION IN PATIENTS WHO HAVEUNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5, 6, 7, OR 8FRENCH PROCEDURAL SHEATH. ADDITIONALLY, THE QUICK-CLOSE VASCULAR SUTURING SYSTEM IS INDICATED TO REDUCE TIME-TO-HEMOSTASIS IN PATIENTS WHO HAVE UNDERGONE INTERVENTIONALENDOVASCULAR PROCEDURES UTILIZING A 5, 6, 7, OR 8 FRENCH PROCEDURAL SHEATH, WHO HAVERECEIVED INTRAPROCEDURAL GLYCOPROTEIN IIB/IIIA INHIBITOR THERAPY.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 
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