FDA 510(k) Application Details - K231629

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K231629
Device Name	Catheter, Percutaneous
Applicant	EOSolutions, Corp. 19700 Sterling Road, Suite 1 Pembroke Pines, FL 33332 US Other 510(k) Applications for this Company
Contact	Marc Litzenberg Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2023
Decision Date	10/31/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review