Shunt Tap
FDA 510(k) K963802 · Integra Neurocare, LLC
510(k) numberK963802
Submission
- Device name
- Shunt Tap
- Applicant
- Integra Neurocare, LLC
Pleasant Prairie, WI, US - Received
- September 23, 1996
- Decision date
- December 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
| K964371 | Shunt Tap with Icp Monitoring Access PortJXG · Traditional | 01/31/1997SE |
Questions and answers
When was Shunt Tap cleared by the FDA?
Shunt Tap (K963802) received a 510(k) decision of Substantially Equivalent on December 12, 1996, 80 days after the submission was received.
What is the product code of K963802?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.