FDA 510(k) Application Details - K231179

Device Classification Name	More FDA Info for this Device
510(K) Number	K231179
Device Name	Slinky Catheter
Applicant	Anoxia Medical, Inc. 3475 Investment Blvd. suite #9 Fremont, CA 94545 US Other 510(k) Applications for this Company
Contact	Henry Nita Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2023
Decision Date	12/01/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review