FDA 510(k) Application Details - K213385

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K213385
Device Name	Device, Vascular, For Promoting Embolization
Applicant	Obsidio, Inc. 1520 Main Street, Unit 4-C Columbia, SC 29201 US Other 510(k) Applications for this Company
Contact	Ehsan Jabbarzadeh 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	10/13/2021
Decision Date	07/01/2022
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