FDA 510(k) Application Details - K100319

Device Classification Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K100319
Device Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant	MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	JEFF CARLSTROM Other 510(k) Applications for this Contact
Regulation Number	870.4290   More FDA Info for this Regulation Number
Classification Product Code	DTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2010
Decision Date	04/28/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review