FDA 510(k) Application Details - K223077

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K223077
Device Name	Catheter, Ultrasound, Intravascular
Applicant	Irvine Biomedical, a St. Jude Medical Company 2375 Morse Ave Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Suzanne Pekarna Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2022
Decision Date	12/07/2022
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