Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves

Shunt, Central Nervous System And Components

Integra LifeSciences Production Corporation

The following data is part of a premarket notification filed by Integra Lifesciences Production Corporation with the FDA for Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves.

Pre-market Notification Details

• Device ID: K221840
• 510k Number: K221840
• Device Name: Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
• Classification: Shunt, Central Nervous System And Components
• Applicant: Integra LifeSciences Production Corporation 11 Cabot Boulevard Mansfield, MA 02048
• Contact: Amanda Erwin
• Correspondent: Amanda Erwin; Integra LifeSciences Production Corporation 11 Cabot Boulevard Mansfield, MA 02048
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-06-24
• Decision Date: 2022-10-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10381780519461	K221840	000
10381780534525	K221840	000
10381780534518	K221840	000
10381780519164	K221840	000
10381780519157	K221840	000
10381780534488	K221840	000
10381780534471	K221840	000
10381780519102	K221840	000
10381780519096	K221840	000
10381780534426	K221840	000
10381780519072	K221840	000
10381780519065	K221840	000
10381780534396	K221840	000
10381780534532	K221840	000
10381780519201	K221840	000
10381780534556	K221840	000
10381780519454	K221840	000
10381780534693	K221840	000
10381780534686	K221840	000
10381780519423	K221840	000
10381780534662	K221840	000
10381780519409	K221840	000
10381780534648	K221840	000
10381780534600	K221840	000
10381780534594	K221840	000
10381780534587	K221840	000
10381780519232	K221840	000
10381780519225	K221840	000
10381780534389	K221840	000
10381780518990	K221840	000
10381780518679	K221840	000
10381780518662	K221840	000
10381780534143	K221840	000
10381780534136	K221840	000
10381780518587	K221840	000
10381780534112	K221840	000
10381780518563	K221840	000
10381780518556	K221840	000
10381780534082	K221840	000
10381780534075	K221840	000
10381780534068	K221840	000
10381780518518	K221840	000
10381780518686	K221840	000
10381780518693	K221840	000
10381780518709	K221840	000
10381780518983	K221840	000
10381780534358	K221840	000
10381780534341	K221840	000
10381780518792	K221840	000
10381780518785	K221840	000
10381780534310	K221840	000
10381780534303	K221840	000
10381780518754	K221840	000
10381780534280	K221840	000
10381780518730	K221840	000
10381780518723	K221840	000
10381780534259	K221840	000
10381780534747	K221840	000
10381780534723	K221840	000
10381780535751	K221840	000
10381780535447	K221840	000
10381780535355	K221840	000
10381780535348	K221840	000
10381780520221	K221840	000
10381780535324	K221840	000
10381780535317	K221840	000
10381780520191	K221840	000
10381780520184	K221840	000
10381780520177	K221840	000
10381780520160	K221840	000
10381780535263	K221840	000
10381780520146	K221840	000
10381780523994	K221840	000
10381780535461	K221840	000
10381780524182	K221840	000
10381780535744	K221840	000
10381780535737	K221840	000
10381780535720	K221840	000
10381780535713	K221840	000
10381780525158	K221840	000
10381780535690	K221840	000
10381780535683	K221840	000
10381780535676	K221840	000
10381780535560	K221840	000
10381780535553	K221840	000
10381780524472	K221840	000
10381780535485	K221840	000
10381780535249	K221840	000
10381780535232	K221840	000
10381780535041	K221840	000
10381780535034	K221840	000
10381780535027	K221840	000
10381780535010	K221840	000
10381780519775	K221840	000
10381780534990	K221840	000
10381780534983	K221840	000
10381780534877	K221840	000
10381780519638	K221840	000
10381780519621	K221840	000
10381780519614	K221840	000
10381780519607	K221840	000
10381780535058	K221840	000
10381780535065	K221840	000
10381780519843	K221840	000
10381780520115	K221840	000
10381780535218	K221840	000
10381780535201	K221840	000
10381780535195	K221840	000
10381780535188	K221840	000
10381780535171	K221840	000
10381780535164	K221840	000
10381780535126	K221840	000
10381780519881	K221840	000
10381780519874	K221840	000
10381780535096	K221840	000
10381780535089	K221840	000
10381780534730	K221840	000