K830000 is an FDA 510(k) clearance for the VASCULAR-ACCESS-PORT. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Norfolk Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on March 1, 1983, 57 days after receiving the submission on January 3, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K830000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1983 |
| Decision Date | March 01, 1983 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |