K771430 is an FDA 510(k) clearance for the BLOOD FILTER, W/SET. This device is classified as a Filter, Infusion Line (Class II - Special Controls, product code FPB).
Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1977, 50 days after receiving the submission on August 1, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K771430 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1977 |
| Decision Date | September 20, 1977 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPB — Filter, Infusion Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |