The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus Intravenous Tubing Sets (nivts).
Device ID | K041861 |
510k Number | K041861 |
Device Name: | NEXUS INTRAVENOUS TUBING SETS (NIVTS) |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-07-09 |
Decision Date | 2004-11-26 |