FDA 510(k) Application Details - K241353

Device Classification Name	More FDA Info for this Device
510(K) Number	K241353
Device Name	PowerLocÖ Max Power Injectable Infusion Set; SafeStepÖ Huber Needle Set
Applicant	Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Catherine Langford Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2024
Decision Date	11/27/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review