The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus Iv Tubing Set With Luer-accessbile One-way Check Valve - Iv Plus.
| Device ID | K130879 |
| 510k Number | K130879 |
| Device Name: | NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS |
| 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 | 2013-03-29 |
| Decision Date | 2013-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30815879021459 | K130879 | 000 |