FDA 510(k) Application Details - K240873

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K240873
Device Name	Device, Vascular, For Promoting Embolization
Applicant	Instylla, Inc. 201 Burlington Rd North Building Bedford, MA 01730 US Other 510(k) Applications for this Company
Contact	Jennifer Greer Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	KRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2024
Decision Date	12/16/2024
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