The following data is part of a premarket notification filed by Yukon Medical, Llc with the FDA for Arisure Neutral Valve.
| Device ID | K120799 |
| 510k Number | K120799 |
| Device Name: | ARISURE NEUTRAL VALVE |
| Classification | Set, Administration, Intravascular |
| Applicant | YUKON MEDICAL, LLC 4819-400 EMPEROR BLVD Durham, NC 27703 |
| Contact | Carl Dupper |
| Correspondent | Mark Job PHARMALINK TECHNICAL GROUP, LLC 20 F STREET, NW Washington, DC 20001 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-03-16 |
| Decision Date | 2012-03-30 |
| Summary: | summary |