LKG · Port & Catheter, Implanted, Subcutaneous, Intraventricular
Neurology · 21 CFR 882.5550 · Class 2
Overview
| Product Code | LKG |
|---|---|
| Device Name | Port & Catheter, Implanted, Subcutaneous, Intraventricular |
| Regulation | 21 CFR 882.5550 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950315 | CORDIS CSF RESERVOIR | Cordis Corp. | May 9, 1995 | SESK |
| K881690 | PORT-A-CATH PORTAL INTRODUCER FORCEPS | Pharmacia Deltec, Inc. | May 20, 1988 | SESE |
| K881493 | PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. | Pharmacia Deltec, Inc. | May 20, 1988 | SESE |
| K874498 | CSF-VENTRICULOSTOMY RESERVOIR | Pudenz-Schulte Medical Research Corp. | Feb 11, 1988 | SESE |
| K874468 | P-S MEDICAL VENTRICULAR ACCESS PORT | Pudenz-Schulte Medical Research Corp. | Feb 11, 1988 | SESE |
| K833822 | P-S MEDICAL CSF ACCESS DEV 15MM/25MM | Pudenz-Schulte Medical Research Corp. | May 25, 1984 | SESE |
| K833672 | HH SUBCUTANEOUS ACCESS PORT | Holter-Hausner Intl. | Mar 6, 1984 | SESE |
| K823790 | VENTRICULAR ACCESS SYSTEM | American Heyer Schulte | Apr 28, 1983 | SESE |
Top Applicants
- Pudenz-Schulte Medical Research Corp. — 3 clearances
- Pharmacia Deltec, Inc. — 2 clearances
- American Heyer Schulte — 1 clearance
- Cordis Corp. — 1 clearance
- Holter-Hausner Intl. — 1 clearance
