FDA 510(k) Application Details - K241946

Device Classification Name	More FDA Info for this Device
510(K) Number	K241946
Device Name	PeritXÖ 1L Drainage Kit (90-1010); PeritXÖ 2L Drainage Kit (90-2010); PeritXÖ Peritoneal Catheter Kit (50-9000C); PeritXÖ Peritoneal Catheter and Starter Kit (50-9900C); PeritXÖ Peritoneal Catheter Mini Kit (50-9050A); PleurXÖ Low Profile Catheter Mini Ki
Applicant	Bard Peripheral Vascular, Inc 1625 W 3rd St Tempe, AZ 85281 US Other 510(k) Applications for this Company
Contact	Gabrielle Wipper Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2024
Decision Date	12/06/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review