510(k) Premarket Notification

• Device Classification Name: filter, intravascular, cardiovascular
• 510(K) Number: K121629
• Models: IGTCFS-65-1-FEM-FT-CELECT-PT, IGTCFS-65-1-JUG-CELECT-PT, IGTCFS-65-1-UNI-FT-CELECT-PT
• Device Name: COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
• Applicant: WILLIAM COOK EUROPE APS; 1 geddes way; west lafayette, IN 47906
• Contact: jennifer brown
• Regulation Number: 870.3375
• Classification Product Code: DTK
• Date Received: 06/04/2012
• Decision Date: 07/03/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No