Starclose Vascular Closure System

FDA premarket approval P050007 · Device, hemostasis, vascular

PMA numberP050007

Approval

Applicant
Abbott Vascular Devices
Received
February 28, 2005
Decision date
December 21, 2005 (APPR)
Supplements
49, latest April 17, 2026
Product code
MGB – Device, Hemostasis, Vascular

Official FDA PMA record

Approval order statement

APPROVAL FOR THE STARCLOSE VASCULAR CLOSURE SYSTEM. THE DEVICE IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.