FDA.reportPublic FDA data

enableCV IntraClude™ Intra-Aortic Occlusion Device

Primary DI
00840479401010
Brand
enableCV IntraClude™ Intra-Aortic Occlusion Device
Company
ENABLECV INC.
Model
ICF100
Device description
IntraClude™ Intra-Aortic Occlusion Device - ICF100
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132175000
K163693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132175000EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETEREdwards Lifesciences, LLC2013-09-13DXC
K163693000IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC2017-01-26DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840479401027PackageGS11In Commercial Distribution
00840479401010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840479401027008404794010278404794010270840479401027
00840479401010008404794010108404794010100840479401010

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE STERILE PACKAGED DEVICE IN A COOL DRY PLACE.

Contacts#

Phone, Email table
PhoneEmail
1(888)943-2783customerservice@enablecv.com

Regulatory Flags#

DUNS number
119247843
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840479400228enableCV Dual Stage Venous Drainage CannulaTR3651B2026-04-30
00840479400402enableCV Thin-Flex Dual Stage Venous Drainage CannulaTF3343OA2026-04-30
00840479401270enableCV Retrograde Cardioplegia CatheterRC014M2026-04-30
00840479401294enableCV Retrograde Cardioplegia CatheterRC092026-04-30
00840479401317enableCV Retrograde Cardioplegia CatheterRC09M2026-04-30
00840479401331enableCV Retrograde Cardioplegia CatheterRC2012M2026-04-30
00840479401355enableCV Retrograde Cardioplegia CatheterRC2014LB2026-04-30
00840479401379enableCV Retrograde Cardioplegia CatheterRC2014M2026-04-30
00840479401478enableCV AViD Dual Stage Venous Drainage CannulaTF2929012026-04-30
00840479401515enableCV Thin-Flex Dual Stage Venous Drainage CannulaTF2937O2026-04-30
00840479401553enableCV Thin-Flex Dual Stage Venous Drainage CannulaTF3646O1202026-04-30
00840479400594enableCV Thin-Flex Single Stage Venous Drainage CannulaTF034L2026-04-27
00840479401577enableCV ThinFlex Single Stage Venous Drainage CannulaTF012L2026-04-27
00840479401591enableCV ThinFlex Single Stage Venous Drainage CannulaTF014L2026-04-27
00840479401614 enableCV ThinFlex Single Stage Venous Drainage CannulaTF018L2026-04-27
00840479401638enableCV ThinFlex Single Stage Venous Drainage CannulaTF018O902026-04-27
00840479401652enableCV ThinFlex Single Stage Venous Drainage CannulaTF020L2026-04-27
00840479401676enableCV ThinFlex Single Stage Venous Drainage CannulaTF022L2026-04-27
00840479401690enableCV ThinFlex Single Stage Venous Drainage CannulaTF024L2026-04-27
00840479401973enableCV ThinFlex Single Stage Venous Drainage CannulaTF016L2026-04-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344138890NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
08022057015884DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635270Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635290Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635370Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
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