FDA 510(k) Application Details - K250292

Device Classification Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days   More FDA Info for this Device
510(K) Number	K250292
Device Name	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant	SkyDance Vascular, Inc. 3058 Millcreek Road Pleasant Grove, UT 84062 US Other 510(k) Applications for this Company
Contact	Scott Pease Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2025
Decision Date	05/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review