BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)— 510(k) K981246

Substantially Equivalent

Integra Neurocare, LLC

FDA 510(k) clearance K981246 for BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730), Substantially Equivalent on 1999-05-26. Applicant: Integra Neurocare, LLC.

Clearance details

Applicant: Integra Neurocare, LLC
Product code: Code JXG
Advisory panel: Neurology
Date received: 1998-04-06
Decision date: 1999-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Prairie, WI, US

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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.