The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Blood Tubing Sets (sterile Fluid Path).
| Device ID | K090255 |
| 510k Number | K090255 |
| Device Name: | BLOOD TUBING SETS (STERILE FLUID PATH) |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence, MA 01843 |
| Contact | Michael Doyle |
| Correspondent | Michael Doyle NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence, MA 01843 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-02 |
| Decision Date | 2009-02-10 |
| Summary: | summary |