Data / Medical devices / United States / Haemonetics Corporation
Haemonetics Corporation: FDA-registered device maker in Salt Lake City, UT, United States, 2 510(k) clearances
Haemonetics Corporation is registered with the FDA (registration 3011773324) in Salt Lake City, UT, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 3, 2010. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011773324
- Address
- 1555 South Gramercy Rd Ste 500, Salt Lake City, UT, United States, 84104
- Owner or operator
- Haemonetics Corporation (1219343)
- Roles
- Manufacturer
- First device listed
- January 24, 2011
- Registered through
- 2026
- Brand names listed
- Cell Saver 5, Cell Saver 5+, Cell Saver Elite, NexSys PCS, Express Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Autotransfusion | CAC | 2 | Manufacturer | accessdata.fda.gov |
| Separator, Automated, Blood Cell, Diagnostic | GKT | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 3, 2010 | K101907 | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | Haemonetics Corp. | accessdata.fda.gov |
| January 5, 1994 | K932890 | CELL SAVER 5 SYSTEM | CAC | Substantially Equivalent | Haemonetics Corp. | accessdata.fda.gov |
Compare with other makers
Updated December 3, 2010. 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.