The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Medisystems Onesite Dual Lumen Needle With Masterguard Anti-stick Needle Protector, Medisystems Onesite Dual Lumen Butto.
| Device ID | K134019 |
| 510k Number | K134019 |
| Device Name: | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO |
| Classification | Needle, Fistula |
| Applicant | NXSTAGE MEDICAL, INC. 350 MERRIMACK STREET Lawrence, MA 01843 |
| Contact | Laura F Plath |
| Correspondent | Laura F Plath NXSTAGE MEDICAL, INC. 350 MERRIMACK STREET Lawrence, MA 01843 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-30 |
| Decision Date | 2014-09-11 |
| Summary: | summary |