The following data is part of a premarket notification filed by Yukon Medical with the FDA for Arisure Dry Spike.
| Device ID | K172631 |
| 510k Number | K172631 |
| Device Name: | Arisure Dry Spike |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | Yukon Medical 4021 Stirrup Creek Dr. Suite #200 Durham, NC 27703 |
| Contact | Todd Korogi |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-09-01 |
| Decision Date | 2017-09-29 |
| Summary: | summary |