FDA 510(k) Application Details - K170029

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K170029
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	INTERNATIONAL BIOPHYSICS CORPORATION 2101 E. ST. ELMO ROAD AUSTIN, TX 78744 US Other 510(k) Applications for this Company
Contact	Geoff Marcek Other 510(k) Applications for this Contact
Regulation Number	870.4360   More FDA Info for this Regulation Number
Classification Product Code	KFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/2017
Decision Date	12/15/2017
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