FDA 510(k) Application Details - K240871

Device Classification Name	Guide, Wire, Catheter, Neurovasculature   More FDA Info for this Device
510(K) Number	K240871
Device Name	Guide, Wire, Catheter, Neurovasculature
Applicant	Enlight Medical Technologies (Shenzhen) Co., Ltd. 5-6/F, Building A, Xinghui Technology Industrial Park 52 Huaning Rd, Xinshi Community, Dalang St, Longhua District Shenzhen 518109 CN Other 510(k) Applications for this Company
Contact	Gui Kason Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	MOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2024
Decision Date	11/18/2024
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