The following data is part of a premarket notification filed by Hemosonics, Llc with the FDA for Quantra Qplus System.
| Device ID | K201513 |
| 510k Number | K201513 |
| Device Name: | Quantra QPlus System |
| Classification | Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties |
| Applicant | HemoSonics, LLC 400 Preston Avenue, Suite 250 Charlottesville, VA 22903 |
| Contact | Anne Zavertnik |
| Correspondent | Anne Zavertnik HemoSonics, LLC 400 Preston Avenue, Suite 250 Charlottesville, VA 22903 |
| Product Code | QFR |
| CFR Regulation Number | 864.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2020-08-21 |