FDA 510(k) Application Details - K213974

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K213974
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	Synovis Micro Companies Alliance, Inc. (a Subsidiary of Baxter International Inc.) 439 Industrial Lane Birmingham, AL 35211 US Other 510(k) Applications for this Company
Contact	Russell Pagano Other 510(k) Applications for this Contact
Regulation Number	870.2100   More FDA Info for this Regulation Number
Classification Product Code	DPW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2021
Decision Date	04/20/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review