K882448 is an FDA 510(k) clearance for the MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on August 9, 1988, 56 days after receiving the submission on June 14, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K882448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1988 |
| Decision Date | August 09, 1988 |
| Days to Decision | 56 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 |