FDA 510(k) Application Details - K222095

Device Classification Name	More FDA Info for this Device
510(K) Number	K222095
Device Name	BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
Applicant	Thrombolex, Inc. 75 New Britain Dr. New Britain, PA 18901 US Other 510(k) Applications for this Company
Contact	Amy Katsikas 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	07/18/2022
Decision Date	04/20/2023
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