K771693 is an FDA 510(k) clearance for the CLIRANS BLOOD LINES SET. This device is classified as a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II - Special Controls, product code FJK).
Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1977, 14 days after receiving the submission on September 6, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K771693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1977 |
| Decision Date | September 20, 1977 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | FJK — Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |