K830788 is an FDA 510(k) clearance for the CENTRAL VEIN CATHERIZATION KIT-14-690-. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on April 30, 1983, 47 days after receiving the submission on March 14, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K830788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1983 |
| Decision Date | April 30, 1983 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |