The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexustko Needleless Access Device, Model Nis-5.
| Device ID | K053129 |
| 510k Number | K053129 |
| Device Name: | NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 |
| Classification | Set, Administration, Intravascular |
| Applicant | NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
| Contact | Al Boedeker |
| Correspondent | Al Boedeker NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-08 |
| Decision Date | 2005-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30892855000028 | K053129 | 000 |