K080807 is an FDA 510(k) clearance for the BLOOD TUBING SETS (STERILE FLUID PATH). This device is classified as a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II - Special Controls, product code FJK).
Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on July 18, 2008, 119 days after receiving the submission on March 21, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K080807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2008 |
| Decision Date | July 18, 2008 |
| Days to Decision | 119 days |
| Submission Type | Special |
| 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 |