FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERITONEAL/CARDIAC CATHETER
K Number: K970983
·
Decision Jun 13, 1997
Classifications
1
FEI Numbers
62
Registration Numbers
63
Same Product Code
252
Applicant Total
12
Review Days
87
Basic Information
- Device Name
- PERITONEAL/CARDIAC CATHETER
- K Number
- K970983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- INTEGRA NEUROCARE LLC.
- Date Received
- March 18, 1997
- Decision Date
- June 13, 1997
- Product Code
- JXG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | FDA class 2 | Neurology |
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Other Clearances by INTEGRA NEUROCARE LLC.
| K Number | Device Name | ||
|---|---|---|---|
| K002392 | VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V | Nov 2, 2000 | Substantially Equivalent |
| K992006 | NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 | Aug 17, 1999 | Substantially Equivalent |
| K981246 | BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) | May 26, 1999 | Substantially Equivalent |
| K973525 | MAURICE WORLDWIDE SHUNT SYSTEM | Dec 16, 1997 | Substantially Equivalent |
| K972994 | EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS | Nov 3, 1997 | Substantially Equivalent |
| K972261 | RIVETTI-LEVINSON INSTRALUMINAL SHUNT | Sep 15, 1997 | Substantially Equivalent |
| K971617 | ENDOSCOPIC VENTRICULAR CATHETER | Jul 31, 1997 | Substantially Equivalent |
| K970658 | LUMBAR DRAINAGE ACCESSORY KIT | May 19, 1997 | Substantially Equivalent |
| K964371 | SHUNT TAP WITH ICP MONITORING ACCESS PORT | Jan 31, 1997 | Substantially Equivalent |
| K961859 | NOVUS STANDARD AND PEDIATRIC VALVES | Dec 16, 1996 | Substantially Equivalent |