FDA 510(k) Application Details - K250439

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K250439
Device Name	Introducer, Catheter
Applicant	Contract Medical International GmbH Lauensteiner Str. 37 Dresden 01277 DE Other 510(k) Applications for this Company
Contact	Jan Kubicek 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	02/14/2025
Decision Date	03/16/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review