The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus Tko-6p Luer Activated Device.
| Device ID | K130416 |
| 510k Number | K130416 |
| Device Name: | NEXUS TKO-6P 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 | 2013-02-19 |
| Decision Date | 2013-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30892855000868 | K130416 | 000 |
| 30892855000509 | K130416 | 000 |
| 30815879021046 | K130416 | 000 |
| 30815879021466 | K130416 | 000 |
| 30815879021602 | K130416 | 000 |
| 30815879021619 | K130416 | 000 |
| 30815879021626 | K130416 | 000 |
| 30815879021633 | K130416 | 000 |
| 30815879021640 | K130416 | 000 |
| 30892855000608 | K130416 | 000 |
| 30892855000615 | K130416 | 000 |
| 30892855000622 | K130416 | 000 |
| 30892855000851 | K130416 | 000 |
| 30892855000790 | K130416 | 000 |
| 30892855000783 | K130416 | 000 |
| 30892855000776 | K130416 | 000 |
| 30892855000769 | K130416 | 000 |
| 30892855000752 | K130416 | 000 |
| 30892855000745 | K130416 | 000 |
| 30892855000721 | K130416 | 000 |
| 30815879021817 | K130416 | 000 |