Port & Catheter, Implanted, Subcutaneous, Intraventricular
Port and Catheter, Implanted, Subcutaneous, Intraventricular is a totally implantable access system consisting of a subcutaneous reservoir (port) connected to a catheter that accesses a cerebral ventricle, used for long-term drug delivery directly into the cerebrospinal fluid or for drainage of cerebrospinal fluid. This is an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKG, regulated under 21 CFR 882.5550, within the Neurology medical specialty. This device is an implant.
Research product code LKG in seconds
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Basic Information
- Product Code
- LKG
- Device Class
- FDA class 2
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950315 | CORDIS CSF RESERVOIR | May 09, 1995 | Unknown | Cordis Corp. |
| K881690 | PORT-A-CATH PORTAL INTRODUCER FORCEPS | May 20, 1988 | Substantially Equivalent | Pharmacia Deltec, Inc. |
| K881493 | PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. | May 20, 1988 | Substantially Equivalent | Pharmacia Deltec, Inc. |
| K874498 | CSF-VENTRICULOSTOMY RESERVOIR | Feb 11, 1988 | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. |
| K874468 | P-S MEDICAL VENTRICULAR ACCESS PORT | Feb 11, 1988 | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. |
| K833822 | P-S MEDICAL CSF ACCESS DEV 15MM/25MM | May 25, 1984 | Substantially Equivalent | Pudenz-Schulte Medical Research Corp. |
| K833672 | HH SUBCUTANEOUS ACCESS PORT | Mar 06, 1984 | Substantially Equivalent | Holter-Hausner Intl. |
| K823790 | VENTRICULAR ACCESS SYSTEM | Apr 28, 1983 | Substantially Equivalent | American Heyer Schulte |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.