Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012690638

FEI Number

3012690638

Entity Name

SIRTEX MEDICAL INC.

City/State/Country

Woburn, MA, US

Establishment Address

300 Unicorn Park Dr., 2nd Fl.,, Woburn, MA 01801, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Sirtex Medical Inc. (Owner Number: 9047689)

Owner / Operator Contact Address

300 Unicorn Park Dr., 2nd Fl., Woburn, MA 01801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202392

PMA Number

N/A

All Registered Proprietary Names

Syringe Shield SIR-Spheres Delivery Box SIROS Delivery Dome LAVA Mixing Kit LAVA Liquid Embolic System (Lava LES) and LAVA Mixing Kit LAVA Liquid Embolic System (LES) LAVA Liquid Embolic System (LES) Kit SIROS D-Vial Prep Set SIR-Spheres V-Vial Holder SIR-Spheres Microspheres Activity Calculator (SMAC)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWR	Holder, Syringe, Lead	Radiology	Class 1	892.6500	2003-12-19
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2003-12-19
QVG	Embolization Agent, Vascular	Unknown	Class 3	N/A	2023-10-23
IWW	Shield, Vial	Radiology	Class 1	892.6500	2003-12-19
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2021-08-11

Official Correspondent

Jeffrey Cyr

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sirtex Medical Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013070673	Sirtex Germany Manufacturing GmbH	Frankfurt am Main Hesse, DE
3009088444	Sirtex Singapore Manufacturing Pte Ltd	Singapore Central Singapore, SG
3005579300	Sirtex Wilmington LLC	Wilmington, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033956	Is2 Research, Inc.	MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)	2004-01-20
K923309	GE Medical Systems	ARGUS PET SYSTEM	1992-09-29
K101768	Miegmbh	MIE SCINTRON GAMMA CAMERA SYSTEMS	2010-10-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2016	Toshiba American Medical Systems Inc	2	Celesteion PCA-9000A/2 PET/CT System
Z-0012-05	General Electric Med Systems LLC	2	Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Z-0013-2007	Philips Medical Systems (Cleveland) Inc	2	Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.
Z-0014-2007	Philips Medical Systems (Cleveland) Inc	2	Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.
Z-0024-2014	GE Healthcare, LLC	2	GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.

Similar Registrations

Registration Number	Establishment Name	Location
3029900933	LEMER PAX AMERICA	Montreal Quebec, CA
3010141508	EBAYGA RADIATION SHIELDING TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3004491626	PINESTAR TECHNOLOGY INC.	JAMESTOWN, PA, US
3014315664	Duopross Meditech (Kunshan) Co., Ltd.	Kunshan Jiangsu, CN
3009088444	Sirtex Singapore Manufacturing Pte Ltd	Singapore Central Singapore, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012690638. Last updated year: 2026. Please use registration number 3012690638 when referencing this establishment in official correspondence.