The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus Pressure Rated Extension Sets.
| Device ID | K092382 |
| 510k Number | K092382 |
| Device Name: | NEXUS PRESSURE RATED EXTENSION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa, KS 66215 |
| Contact | Susan Curry |
| Correspondent | Susan Curry 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 | 2009-08-05 |
| Decision Date | 2010-04-26 |