FDA 510(k) Application Details - K242756

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K242756
Device Name	Introducer, Catheter
Applicant	Pulnovo Medical (Wuxi) Co., Ltd 3rd Fl, Bldg D 17, No. 1719-17 Huishan Ave, & 3rd Flr, Bldg D 11, No. 1719-11, Huishan Ave, Huishan Economic Dev Zone Wuxi 214000 CN Other 510(k) Applications for this Company
Contact	Wen Gu Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2024
Decision Date	11/08/2024
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