FDA.reportPublic FDA data

Venclose Maven Catheter

Primary DI
00858254006398
Brand
Venclose Maven Catheter
Company
VENCLOSE INC
Model
VC056F
Device description
Venclose Perforator Catheter
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211806000Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven CatheterVenclose, Inc.2021-08-03GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858254006404PackageGS15In Commercial Distribution
00858254006411PackageGS110In Commercial Distribution
00858254006398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858254006404008582540064048582540064040858254006404
00858254006411008582540064118582540064110858254006411
00858254006398008582540063988582540063980858254006398

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular electrocautery catheter, single-useA flexible catheter with a distal heating element/electrode intended to be connected to an electrical generator and introduced into the peripheral vasculature to ablate venous tissues, through direct application of heat, as a treatment for venous reflux disease (varicose veins); it is not intended to introduce electrical current into the body. It is a luminal device with a proximal handle with controls (e.g., on/off switch) that is introduced via an introducer assembly (which may be included), and is typically maneuvered under external image guidance [e.g., ultrasound (US)]. This is a single-use device.

Regulatory Flags#

DUNS number
085838983
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
00858254006008Venclose System EVSRF CatheterVC10A256F602016-11-01
00858254006015Venclose System EVSRF CatheterVC10A256F1002016-11-01
00858254006022Venclose System digiRF GeneratorVCRFG12016-11-01
00858254006046Venclose System Power CordVCPCB2016-11-01
00858254006053Venclose System Power CordVCPCE2016-11-01
00858254006060Venclose System Power CordVCPCG2016-11-01
00858254006077Venclose System Power CordVCPCC2016-11-01
00858254006084Venclose System Power CordVCPCI2016-11-01
00858254006091Venclose System Power CordVCPCN2016-11-01
00858254006107Venclose System Power CordVCPCL2016-11-01
00858254006114Venclose System Power CordVCPCK2016-11-01
00858254006121Venclose System Power CordVCPCM2016-11-01
00858254006138Venclose System Power CordVCPCH2016-11-01
00858254006145Venclose System Power CordVCPCJ2016-11-01
00858254006152Venclose System Power CordVCPCA2016-11-01
00858254006404Venclose Maven CatheterVC056F2021-09-01
00858254006039Venclose System Foot PedalVCFP12016-11-01
00858254006169Venclose™ EVSRF™ CatheterVC-10A2.5-6F-60 [5X]2016-11-01
00858254006176Venclose™ EVSRF™ CatheterVC-10A2.5-6F-100 [5X]2016-11-01
00858254006183Venclose™ EVSRF™ CatheterVC-10A2.5-6F-60 [10X]2016-11-01

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Primary DI, Brand, Company table
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