FDA.reportPublic FDA data

LAVA Mixing Kit, 6 mL

Primary DI
00850055697058
Brand
LAVA Mixing Kit, 6 mL
Company
Sirtex Medical Inc.
Model
SLLESMK6
Device description
LAVA Mixing Kit, 6 mL (to homogenize the liquid embolic suspension)
Published
2023-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QVGEmbolization Agent, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVGEmbolization Agent, VascularUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220020006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220020006Lava Liquid Embolic System (Lava LES) and Lava Mixing KitSirtex Medical, Inc.2023-04-04QVG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850055697058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850055697058008500556970588500556970580850055697058

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization plug, synthetic polymer, non-bioabsorbableA non-bioabsorbable device intended to be implanted in a peripheral (non-neurovascular) artery for permanent/long-term occlusion of blood flow to treat haemorrhage. It is in the form of an injectable synthetic polymer solution [e.g., dissolved ethylene vinyl alcohol (EVOH)] that solidifies in situ to form a coherent embolus requiring no thrombosis to create blockage; radiopaque metal (e.g., tantalum) powder may be included to assist fluoroscopic visualization. It is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.

Contacts#

Phone, Email table
PhoneEmail
1-888-474-7839csusa@sirtex.com

Regulatory Flags#

DUNS number
127504939
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850055697003LAVA-18, 2 mLSLLES1822023-10-23
00850055697010LAVA-34, 2 mLSLLES3422023-10-23
00850055697027LAVA-18, 6 mLSLLES1862023-10-23
00850055697034LAVA-34, 6 mLSLLES3462023-10-23
00850055697041LAVA Mixing Kit, 2 mLSLLESMK22023-10-23
00850014612153SIR-Spheres Y-90 resin microspheresSIR-Y0032026-05-28
00850014612030SIR-Spheres Y-90 resin microspheresSIR-Y0012024-07-15
00850014612146SIR-Spheres Y-90 resin microspheresSIR-Y0022024-03-28
00850014612108SIR-Spheres® Microspheres Activity Calculator (SMAC)X-SMAC-012021-08-16
00850014612061SIR-Spheres V-VialSIR-V0012021-07-15
00850014612047SIR-Spheres Delivery ApparatusSIR-B0012021-07-14
00850014612054SIR-Spheres Delivery SetSIR-D0012021-07-14
00850014612078SIR-Spheres V-Vial HolderSIR-H0012021-07-14
00850014612092SIR-Spheres Accessories PackSIR-K0022021-07-14
00850014612085SIR-Spheres Syringe ShieldSIR-S0012021-07-09
00850014612009SIROS Delivery DomeSIR-10100SIR-101002021-01-05
00850014612016SIROS D-Vial Prep SetSIR-10200SIR-102002021-01-05
00850014612023SIROS Delivery SetSIR-10300SIR-103002021-01-05
M425SIRY0010SIR-Spheres microspheresSIR-Y0012014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812013030215Embrace Hydrogel Embolic System (HES)Instylla Inc.QVG2025-12-01
00850055697003LAVA-18, 2 mLSirtex Medical Inc.QVG2023-10-23
00850055697010LAVA-34, 2 mLSirtex Medical Inc.QVG2023-10-23
00850055697027LAVA-18, 6 mLSirtex Medical Inc.QVG2023-10-23
00850055697034LAVA-34, 6 mLSirtex Medical Inc.QVG2023-10-23
00850055697041LAVA Mixing Kit, 2 mLSirtex Medical Inc.QVG2023-10-23