Data / Medical devices / United States / Coreva Health Science, LLC
Coreva Health Science, LLC: FDA-registered device maker in Westlake Village, CA, United States, 1 510(k) clearance
Coreva Health Science, LLC is registered with the FDA (registration 3006324197) in Westlake Village, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 24, 2014. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006324197
- Address
- 2985 E Hillcrest Dr Ste 205, Westlake Village, CA, United States, 91362
- Owner or operator
- COREVA HEALTH SCIENCE, LLC (9102880)
- Roles
- Repackager or relabeler
- First device listed
- January 20, 2015
- Registered through
- 2026
- Brand names listed
- ActCel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 24, 2014 | K140573 | WOUNDCLOT HEMOSTATIC GAUZE | QSY | Substantially Equivalent | Core Scientific , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 18, 2015 | 71279 | Class II | Terminated | ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of co | Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature and web sites promoting that it can help control bleeding from open wounds and in body cavities. ActCel is indicated as a prescription device for management of topical wounds and to temporarily control external surface bleeding. | accessdata.fda.gov |
Compare with other makers
Updated May 30, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.