FDA 510(k) Application Details - K242692

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K242692
Device Name	Set, Administration, Intravascular
Applicant	Capillary Biomedical, LLC. 2 Wrigley, Suite 100 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Kristina Nistler Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2024
Decision Date	05/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review