Integra Neurocare, LLC
San Diego, CA, US
Integra Neurocare, LLC appears in FDA device records in San Diego, CA. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Integra Neurocare, LLC between 1996 and 2000. The busiest year on record is 1997, with 7. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 1997 | 7 |
| 1999 | 2 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K002392 | VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V | GWM | Substantially Equivalent | |
| K992006 | NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 | OCV | Substantially Equivalent | |
| K981246 | BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) | JXG | Substantially Equivalent | |
| K973525 | MAURICE WORLDWIDE SHUNT SYSTEM | JXG | Substantially Equivalent | |
| K972994 | EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS | JXG | Substantially Equivalent | |
| K972261 | RIVETTI-LEVINSON INSTRALUMINAL SHUNT | DWF | Substantially Equivalent | |
| K971617 | ENDOSCOPIC VENTRICULAR CATHETER | JXG | Substantially Equivalent | |
| K970983 | PERITONEAL/CARDIAC CATHETER | JXG | Substantially Equivalent | |
| K970658 | LUMBAR DRAINAGE ACCESSORY KIT | JXG | Substantially Equivalent | |
| K964371 | SHUNT TAP WITH ICP MONITORING ACCESS PORT | JXG | Substantially Equivalent | |
| K961859 | NOVUS STANDARD AND PEDIATRIC VALVES | JXG | Substantially Equivalent | |
| K963802 | SHUNT TAP | JXG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain