FDA 510(k) Application Details - K190619

Device Classification Name	More FDA Info for this Device
510(K) Number	K190619
Device Name	Aspiron(TM) Aspiration Catheter
Applicant	Meril Life Sciences Private Limited Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi 396191 IN Other 510(k) Applications for this Company
Contact	Utpal Thakor Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2019
Decision Date	04/29/2019
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