K090255 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 February 10, 2009, 8 days after receiving the submission on February 2, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K090255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2009 |
| Decision Date | February 10, 2009 |
| Days to Decision | 8 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 |