K834383 is an FDA 510(k) clearance for the DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Burron Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on May 1, 1984, 139 days after receiving the submission on December 14, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K834383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1983 |
| Decision Date | May 01, 1984 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |