FDA 510(k) Application Details - K193071

Device Classification Name	More FDA Info for this Device
510(K) Number	K193071
Device Name	Bashir Plus Endovascular Catheter
Applicant	Thrombolex, Inc. 75 New Britain Dr. New Britain, PA 18901 US Other 510(k) Applications for this Company
Contact	Amy Katsikis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2019
Decision Date	12/17/2019
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