FDA 510(k) Application Details - K211314

Device Classification Name	System&Accessories,Isolated Heart,Transport&Preservation   More FDA Info for this Device
510(K) Number	K211314
Device Name	System&Accessories,Isolated Heart,Transport&Preservation
Applicant	TransMedics, Inc. 200 Minuteman Road, Suite 302 Andover, MA 01810 US Other 510(k) Applications for this Company
Contact	Miriam Provost Other 510(k) Applications for this Contact
Regulation Number	876.5880   More FDA Info for this Regulation Number
Classification Product Code	MSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2021
Decision Date	07/29/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review