SHUNT TAP— 510(k) K963802
Substantially EquivalentIntegra Neurocare, LLC
FDA 510(k) clearance K963802 for SHUNT TAP, Substantially Equivalent on 1996-12-12. Applicant: Integra Neurocare, LLC. Device class: 2.
Clearance details
- Applicant
- Integra Neurocare, LLC
- Product code
- Code JXG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5550
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasant Prairie, WI, US
Recent devices under product code JXG
view allMore clearances from Integra Neurocare, LLC
view all- K002392 — VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
- K992006 — NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
- K981246 — BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
- K973525 — MAURICE WORLDWIDE SHUNT SYSTEM
- K972994 — EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS
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, through . 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.