FDA 510(k) Application Details - K243418

Device Classification Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered   More FDA Info for this Device
510(K) Number	K243418
Device Name	Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant	Micro Therapeutics Inc. d/b/a ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Tony Rizzardi Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	JCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2024
Decision Date	12/02/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review