Shunt Tap with Icp Monitoring Access Port

Q: What is the product code of K964371?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.

FDA 510(k) K964371 · Integra Neurocare, LLC

Substantially Equivalent

510(k) numberK964371

Submission

Device name: Shunt Tap with Icp Monitoring Access Port
Applicant: Integra Neurocare, LLC
Pleasant Prairie, WI, US
Received: November 1, 1996
Decision date: January 31, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: JXG – Shunt, Central Nervous System And Components
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5550
Specialty: Neurology
Implant: Yes

Other 510(k)s with product code JXG

510(k)	Device	Applicant	Decision
K261004	Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional	Integra Lifesciences Production Corporation	06/23/2026SE
K251598	IntellidropJXG · Traditional	Brainspace, Inc.	12/10/2025SE
K250636	Sophy Mini Monopressure Valve (SM1)JXG · Traditional	Sophysa	11/28/2025SE
K252514	Evac-MriJXG · Traditional	Phasor Health, LLC	11/05/2025SESD
K243531	Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional	Integra Lifesciences Production Corporation	08/08/2025SE
K243552	Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional	Integra Lifesciences Production Corporation	08/06/2025SE
K242974	External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional	Sophysa	06/20/2025SE
K243205	EvacJXG · Traditional	Phasor Health, LLC	06/03/2025SE
K243676	Duet External Drainage and Monitoring System (EDMS)JXG · Traditional	Medtronic Neurosurgery	03/10/2025SE
K242003	XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional	Aesculap, Inc.	12/16/2024SE

More from Aesculap, Inc.

510(k)	Device	Decision
K002392	Ventrix True Tech Ventricular Tunneling Pressure Monitoring Kit, Model NL960-VGWM · Traditional	11/02/2000SE
K992006	Neuroview Instrument Holder, Model 300-33OCV · Traditional	08/17/1999SE
K981246	Beverly Referential Valve (NL850-9710) with Integral Peritoneal Catheter (NL850-9720)…JXG · Traditional	05/26/1999SE
K973525	Maurice Worldwide Shunt SystemJXG · Traditional	12/16/1997SE
K972994	External CSF Drainage Management SystemsJXG · Traditional	11/03/1997SE
K972261	Rivetti-Levinson Instraluminal ShuntDWF · Traditional	09/15/1997SE
K971617	Endoscopic Ventricular CatheterJXG · Traditional	07/31/1997SE
K970983	Peritoneal/Cardiac CatheterJXG · Traditional	06/13/1997SE
K970658	Lumbar Drainage Accessory KitJXG · Traditional	05/19/1997SE
K961859	Novus Standard and Pediatric ValvesJXG · Traditional	12/16/1996SE

Questions and answers

When was Shunt Tap with Icp Monitoring Access Port cleared by the FDA?

Shunt Tap with Icp Monitoring Access Port (K964371) received a 510(k) decision of Substantially Equivalent on January 31, 1997, 91 days after the submission was received.

What is the product code of K964371?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.