FDA 510(k) Application Details - K141060

Device Classification Name	More FDA Info for this Device
510(K) Number	K141060
Device Name	CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
Applicant	ON-X LIFE TECHNOLOGIES, INC. 1300 East anderson Lane Building B Austin, TX 78752 US Other 510(k) Applications for this Company
Contact	JOHN ELY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2014
Decision Date	06/06/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review