Sirtex Medical, Inc.
FDA registration: United States Last updated 25 Oct 2026
- Devices
- 22
- Registries
- GUDIDFDA PMA
- FDA recalls
- 2
Catalogue
SIR-Spheres Y-90 resin microspheres SIR-Y003 Ref SIR-Y003
SIR-Spheres Syringe Shield SIR-S001 Ref SIR-S001
LAVA-34, 6 mL SLLES346 Ref SLLES346
LAVA-34, 2 mL SLLES342 Ref SLLES342
SIROS D-Vial Prep Set SIR-10200 Ref SIR-10200
SIR-Spheres Delivery Apparatus SIR-B001 Ref SIR-B001
LAVA-18, 6 mL SLLES186 Ref SLLES186
SIR-Spheres V-Vial Holder SIR-H001 Ref SIR-H001
SIROS Delivery Set SIR-10300 Ref SIR-10300
SIROS Delivery Dome SIR-10100 Ref SIR-10100
SIR-Spheres Y-90 resin microspheres SIR-Y001 Ref SIR-Y001
SIR-Spheres Delivery Set SIR-D001 Ref SIR-D001
SIR-Spheres V-Vial SIR-V001 Ref SIR-V001
SIR-Spheres microspheres SIR-Y001 Ref SIR-Y001
SIR-Spheres Accessories Pack SIR-K002 Ref SIR-K002
SIR-Spheres Y-90 resin microspheres SIR-Y002 Ref SIR-Y002
LAVA Mixing Kit, 6 mL SLLESMK6 Ref SLLESMK6
LAVA Mixing Kit, 2 mL SLLESMK2 Ref SLLESMK2
LAVA-18, 2 mL SLLES182 Ref SLLES182
Sir-Spheres Ref P990065
FDA recalls
2021
- 22 Feb 2021 Z-1275-2021 Class II Terminated There is a potential presence of particulate matter in the D-Vial.
2013
- 27 Feb 2013 Z-1162-2013 Class III Terminated Incorrect expiration date
What Sirtex Medical, Inc. makes
Sirtex Medical, Inc. manufactures the Lava Liquid Embolic System (LES) and its associated mixing kit, used for liquid embolization procedures, as well as SIR-SPHERES, which are microspheres for transarterial embolization therapies.
The company’s products are classified as Class III medical devices and are listed under the FDA’s Premarket Approval (PMA) pathway. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Sirtex Medical, Inc. manufacture?
Sirtex Medical, Inc. specializes in embolization therapies. Their primary products include the Lava Liquid Embolic System (LES) and Lava Mixing Kit, designed for liquid embolization procedures, as well as SIR-SPHERES, which are microspheres used in transarterial embolization to block blood flow to targeted tissues. These devices are intended for interventional radiology and oncology applications.
Where is Sirtex Medical, Inc. based, and how does that affect its regulatory approach?
Sirtex Medical, Inc. is headquartered in the United States, which means its devices must comply with FDA regulations. Since embolization therapies are high-risk procedures, the company’s products fall under Class III classification, requiring stringent premarket approval (PMA) to demonstrate safety and effectiveness before commercialization.
Which regulatory registries or databases list Sirtex Medical, Inc.’s devices?
Sirtex Medical, Inc.’s devices are listed under the FDA’s Premarket Approval (PMA) pathway, meaning they undergo rigorous review and authorization before being marketed. While the company itself isn’t listed in registries, its authorized devices (e.g., Lava LES, SIR-SPHERES) are tracked in the FDA’s PMA database as Class III medical devices.
Why are Sirtex Medical, Inc.’s devices classified as Class III?
The Class III designation applies to devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury if they fail. Embolization therapies—such as those provided by Sirtex’s LES and SIR-SPHERES—fall into this category because they involve precise vascular interventions where device failure could lead to severe complications, like organ damage or uncontrolled bleeding.
Information
- FDA registration
- United States
- Website
- sirtex.com
- [email protected]
- Phone
- 1-888-474-7839
- DUNS number
- 127504939