K854562 is an FDA 510(k) clearance for the CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I. This device is classified as a Set, Blood Transfusion (Class II - Special Controls, product code BRZ).
Submitted by Medelec Intl. Corp. (Miami Beach, US). The FDA issued a Cleared decision on January 9, 1986, 56 days after receiving the submission on November 14, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K854562 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 1985 |
| Decision Date | January 09, 1986 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | BRZ — Set, Blood Transfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |