Data / Medical devices / United States / Shire Human Genetic Therapies, Inc.
Shire Human Genetic Therapies, Inc.: FDA-registered device maker in Lexington, MA, United States, 3 510(k) clearances
Shire Human Genetic Therapies, Inc. is registered with the FDA (registration 3009340644) in Lexington, MA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated October 30, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009340644
- Address
- 300 Shire Way, Lexington, MA, United States, 02421
- Owner or operator
- Takeda Pharmaceuticals U.S.A., Inc. (10051446)
- Roles
- Specification developer
- First device listed
- January 19, 2018
- Registered through
- 2026
- Brand names listed
- Baxject II Hi-Flow Needleless Transfer Device, Baxject II Needleless Transfer Device, Cinryze
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 30, 2009 | K092318 | BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE | LHI | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| October 8, 2004 | K042410 | BAXJECT II | LHI | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| July 29, 2003 | K031861 | MIX2VIAL TRANSFER DEVICE | LHI | Substantially Equivalent | Medimop Medical Projects, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 30, 2009. 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.