FDA 510(k) Application Details - K211061

Device Classification Name	More FDA Info for this Device
510(K) Number	K211061
Device Name	BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)
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	04/09/2021
Decision Date	06/10/2021
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