FDA 510(k) Application Details - K200459

Device Classification Name	Catheter, Intravascular Occluding, Temporary   More FDA Info for this Device
510(K) Number	K200459
Device Name	Catheter, Intravascular Occluding, Temporary
Applicant	Prytime Medical Devices, Inc. 229 North Main Street Boerne, TX 78006 US Other 510(k) Applications for this Company
Contact	Brian Young Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	MJN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2020
Decision Date	06/03/2020
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