The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus Tko-6, Luer-activated Device.
| Device ID | K113398 |
| 510k Number | K113398 |
| Device Name: | NEXUS TKO-6, LUER-ACTIVATED DEVICE |
| Classification | Set, Administration, Intravascular |
| Applicant | NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
| Contact | Heather Turner |
| Correspondent | Heather Turner NEXUS MEDICAL, LLC 11315 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 | 2011-11-17 |
| Decision Date | 2012-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30892855000929 | K113398 | 000 |
| 30892855000912 | K113398 | 000 |
| 30892855000905 | K113398 | 000 |
| 30892855000899 | K113398 | 000 |
| 30892855000882 | K113398 | 000 |
| 30892855000431 | K113398 | 000 |