K772040 is an FDA 510(k) clearance for the TRANSDUCER PROTECTOR. This device is classified as a Filter, Blood, Dialysis (Class II - Special Controls, product code FKJ).
Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1977, 31 days after receiving the submission on October 28, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K772040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1977 |
| Decision Date | November 28, 1977 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | FKJ — Filter, Blood, Dialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |