K760381 is an FDA 510(k) clearance for the BLOOD TRANSFUSION SET (SANGOFIX). This device is classified as a Catheter, Infusion (Class I - General Controls, product code JCY).
Submitted by B. Braun Instruments (Mchenry, US). The FDA issued a Cleared decision on November 2, 1976, 89 days after receiving the submission on August 5, 1976.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K760381 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1976 |
| Decision Date | November 02, 1976 |
| Days to Decision | 89 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 |