QuikClot Control+
Temporary, Internal Use Hemostatic
Z-Medica, LLC
The following data is part of a premarket notification filed by Z-medica, Llc with the FDA for Quikclot Control+.
Pre-market Notification Details
| Device ID | K200167 |
| 510k Number | K200167 |
| Device Name: | QuikClot Control+ |
| Classification | Temporary, Internal Use Hemostatic |
| Applicant | Z-Medica, LLC 4 Fairfield Boulevard Wallingford, CT 06492 |
| Contact | Soraya King |
| Correspondent | Soraya King Z-Medica, LLC 4 Fairfield Boulevard Wallingford, CT 06492 |
| Product Code | POD |
| CFR Regulation Number | 878.4454 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-23 |
| Decision Date | 2020-04-23 |
Trademark Results [QuikClot Control+]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUIKCLOT CONTROL+ 86913152 5375870 Live/Registered |
Z-MEDICA, LLC 2016-02-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.