FDA.reportPublic FDA data

Venclose Maven Catheter

Primary DI
00858254006404
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
085838983
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
true
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
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
00858254006398Venclose 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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