Beverly Referential Valve (NL850-9710) with Integral Peritoneal Catheter (NL850-9720) Valve Kit (NL850-9730)
FDA 510(k) K981246 · Integra Neurocare, LLC
510(k) numberK981246
Submission
- Device name
- Beverly Referential Valve (NL850-9710) with Integral Peritoneal Catheter (NL850-9720) Valve Kit (NL850-9730)
- Applicant
- Integra Neurocare, LLC
Pleasant Prairie, WI, US - Received
- April 6, 1998
- Decision date
- May 26, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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 |
| 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 |
| K961859 | Novus Standard and Pediatric ValvesJXG · Traditional | 12/16/1996SE |
Questions and answers
When was Beverly Referential Valve (NL850-9710) with Integral Peritoneal Catheter (NL850-9720) Valve Kit (NL850-9730) cleared by the FDA?
Beverly Referential Valve (NL850-9710) with Integral Peritoneal Catheter (NL850-9720) Valve Kit (NL850-9730) (K981246) received a 510(k) decision of Substantially Equivalent on May 26, 1999, 415 days after the submission was received.
What is the product code of K981246?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.