K834615 is an FDA 510(k) clearance for the TRIPLE LUMEN INFUSIONCATHETERS-. This device is classified as a Catheter, Infusion (Class I - General Controls, product code JCY).
Submitted by Medical Components, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 14, 1984, 72 days after receiving the submission on December 4, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K834615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 1983 |
| Decision Date | February 14, 1984 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | JCY — Catheter, Infusion |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |