K001107 is an FDA 510(k) clearance for the FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP). This device is classified as a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II - Special Controls, product code FJK).
Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on June 23, 2000, 79 days after receiving the submission on April 5, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K001107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2000 |
| Decision Date | June 23, 2000 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJK — Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |