FDA 510(k) Application Details - K251358

Device Classification Name	Catheter, Intravascular Occluding, Temporary   More FDA Info for this Device
510(K) Number	K251358
Device Name	Catheter, Intravascular Occluding, Temporary
Applicant	Philips Image Guided Therapy Devices 9965 Federal Dr Colorado Springs, CO 80921 US Other 510(k) Applications for this Company
Contact	Sondra Chandler Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	MJN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2025
Decision Date	06/24/2025
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