FDA 510(k) Application Details - K211910

Device Classification Name	Catheter, Septostomy   More FDA Info for this Device
510(K) Number	K211910
Device Name	Catheter, Septostomy
Applicant	NuMED, Inc. 2880 Main Street Hopkinton, NY 12965 US Other 510(k) Applications for this Company
Contact	Nichelle LaFlesh Other 510(k) Applications for this Contact
Regulation Number	870.5175   More FDA Info for this Regulation Number
Classification Product Code	DXF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2021
Decision Date	07/19/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review