The following data is part of a premarket notification filed by Nexus Medical Llc with the FDA for Nexus Nis-6p Luer Activated Device.
| Device ID | K133351 |
| 510k Number | K133351 |
| Device Name: | NEXUS NIS-6P LUER ACTIVATED DEVICE |
| Classification | Set, Administration, Intravascular |
| Applicant | NEXUS MEDICAL LLC 1113 STRANG LINE ROAD Lenexa, KS 66215 |
| Contact | Heather Turner |
| Correspondent | Heather Turner NEXUS MEDICAL LLC 1113 STRANG LINE ROAD Lenexa, KS 66215 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-31 |
| Decision Date | 2014-05-22 |
| Summary: | summary |