FDA 510(k) Application Details - K231653

Device Classification Name	More FDA Info for this Device
510(K) Number	K231653
Device Name	BASHIRÖ .035 Endovascular Catheter, BASHIRÖ S-B .035 Endovascular Catheter
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	06/06/2023
Decision Date	07/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review