Data / Medical devices / United States / Sirtex Wilmington LLC
Sirtex Wilmington LLC: FDA-registered device maker in Wilmington, MA, United States, 2 PMA approvals
Sirtex Wilmington LLC is registered with the FDA (registration 3005579300) in Wilmington, MA, United States. It lists 6 device types. The FDA files 2 PMA approvals under its listings, the newest dated April 4, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005579300
- Address
- 16 Upton Drive Unit 2-4, Wilmington, MA, United States, 01887
- Owner or operator
- Sirtex Medical Inc. (9047689)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 19, 2003
- Registered through
- 2026
- Brand names listed
- LAVA Liquid Embolic System (LES), LAVA Liquid Embolic System (LES) Kit, LAVA Liquid Embolic System (Lava LES) and LAVA Mixing Kit, LAVA Mixing Kit, SIR-Spheres, SIR-Spheres Accessories Pack, SIR-Spheres Delivery Box, SIR-Spheres Delivery Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Embolization Agent, Vascular | QVG | 3 | Manufacturer | accessdata.fda.gov |
| Holder, Syringe, Lead | IWR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Microspheres Radionuclide | NAW | 3 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Shield, Vial | IWW | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Applicator, Radionuclide, Manual | IWJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 4, 2023 | P220020 | Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit | QVG | 8 | July 9, 2026 | accessdata.fda.gov |
| March 5, 2002 | P990065 | SIR-SPHERES | NAW | 14 | May 7, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Shield, Protective, Personnel
- All makers of Holder, Syringe, Lead
- All makers of System, Applicator, Radionuclide, Manual
- All makers of Microspheres Radionuclide
- All makers of Shield, Vial
- All makers of Embolization Agent, Vascular
Updated July 9, 2026. 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.