FDA.reportPublic FDA data

EVO

Primary DI
04033817900504
Brand
EVO
Company
LivaNova Deutschland GmbH
Model
Occluder
Published
2015-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082344000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082344000STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)Sorin Group Deutschland GmbH2008-12-17DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04033817900504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04033817900504040338179005044033817900504

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system, roller typeAn assembly of devices that provides mechanical circulatory support during open-heart surgery, bypassing the heart to facilitate surgery on the organ. The basic function of the machine is to oxygenate the body's venous supply of blood and then pump it back into the arterial circuit. It will typically provide intracardiac suction, filtration, and temperature control. This device typically consists of mains electricity (AC-powered) console with roller pumps, oxygenators, a heat exchanger, temperature regulators, a reservoir, filters, a defoamer, and a handcrank for manual emergency rotation of a blood pump. Some systems are manufactured as a single unit while others are made up of modules.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343225272
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
34033817902394Level ControlPads2026-07-20
04033817904137DeviceHOLDER WITH MAST-CLAMP LONG2026-01-22
04033817904144DeviceCOCKPITARM - VARIABLE HEIGHT2026-01-22
04033817753070XVAC100-120V2015-10-20
04033817900696Electronic Gas Blender10 l/min2015-10-16
04033817900702Electronic Gas Blender5 l/min2015-10-20
04033817900719Electronic Gas Blender2 l/min2015-10-14
04033817752219XTRA100-120V2015-10-16
04033817901693Virtual Kit NumberS5 LUFTBLASENÜBWERWACHUNG APC2024-07-23
04033817900474S5 Mast Roller PumpMRP 1502015-10-14
04033817900481S5 Mast Roller PumpMRP 852015-10-14
04033817900726B-Care5Sensor Module (venous)2015-10-16
04033817900818S5 Mast Roller PumpControl Panel for 1 MRP2015-10-20
04033817901075B-Care5Venous Sensor (complete)2015-10-20
04033817901150InterfaceModule DDD2015-10-20
04033817902423AccessoriesBubble Sensor 3/16“ x 1/16”2023-03-21
04033817902430AccessoriesBubble Sensor 1/4“ x 1/16“2023-03-21
04033817902447AccessoriesBubble Sensor 3/8“ x 3/32“2023-03-21
04033817902454AccessoriesBubble Sensor 1/2“ x 3/32“2023-03-21
04033817902461AccessoriesFlow Sensor 3/16“ x 1/16”2023-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479402178enableCV QuickDraw™ Plus Venous CannulaENABLECV INC.DWF2026-08-27
00824846013419NAMEDTRONIC, INC.DWF2026-08-23
00824846013501NAMEDTRONIC, INC.DWF2026-08-23
00824846012962NAMEDTRONIC, INC.DWF2026-08-14
00824846013099NAMEDTRONIC, INC.DWF2026-08-14
00824846005445NAMEDTRONIC, INC.DWF2026-07-30
00824846005469NAMEDTRONIC, INC.DWF2026-07-30
00824846005667NAMEDTRONIC, INC.DWF2026-07-30
00824846006022NAMEDTRONIC, INC.DWF2026-07-30
00824846007944NAMEDTRONIC, INC.DWF2026-07-30
00840479401096enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401119enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401133enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401157enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401171enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401195enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00824846004721NAMEDTRONIC, INC.DWF2026-07-19
00824846004738NAMEDTRONIC, INC.DWF2026-07-19
00824846004028NAMEDTRONIC, INC.DWF2026-07-16
00824846003151NAMEDTRONIC, INC.DWF2026-07-09
00840479401416enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00824846003472NAMEDTRONIC, INC.DWF2026-07-04
00824846003687NAMEDTRONIC, INC.DWF2026-07-04
00824846003700NAMEDTRONIC, INC.DWF2026-07-04
00824846001669NAMEDTRONIC, INC.DWF2026-06-28
00824846001843NAMEDTRONIC, INC.DWF2026-06-28
00824846001850NAMEDTRONIC, INC.DWF2026-06-28
00840479402222enableCV Percutaneous Insertion Kit-ArterialENABLECV INC.DWF2026-06-26
00824846001614NAMEDTRONIC, INC.DWF2026-06-25