The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for All Safe Huber Safety Infusion Set.
| Device ID | K142590 |
| 510k Number | K142590 |
| Device Name: | All Safe Huber Safety Infusion Set |
| 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 | 2014-09-15 |
| Decision Date | 2015-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30815879020988 | K142590 | 000 |
| 30815879020889 | K142590 | 000 |
| 30815879020896 | K142590 | 000 |
| 30815879020902 | K142590 | 000 |
| 30815879020919 | K142590 | 000 |
| 30815978020926 | K142590 | 000 |
| 30815879020933 | K142590 | 000 |
| 30815879020940 | K142590 | 000 |
| 30815879020957 | K142590 | 000 |
| 30815879020964 | K142590 | 000 |
| 30815879020971 | K142590 | 000 |
| 30815879020872 | K142590 | 000 |