FDA.reportPublic FDA data

VenaCure EVLT

Primary DI
H787114030010
Brand
VenaCure EVLT
Company
ANGIODYNAMICS, INC.
Model
11403001
Device description
NeverTouch FRS 45cm Procedure Kit
Published
2016-09-20
Public version status
Update
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
GEXPowered laser surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112600000
K162914000
K171921000
K231945000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112600000ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KITAngioDynamics, Inc.2012-01-30GEX
K162914000VenaCure EVLT NeverTouch Procedure KitAngioDynamics, Inc.2016-11-16GEX
K171921000VenaCure EVLT NeverTouch Procedure KitAngioDynamics, Inc.2017-08-24GEX
K231945000VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsAngioDynamics, Inc.2023-07-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787114030010PrimaryHIBCC0
15051684014489SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168401448915051684014489

GMDN Terms#

Term, Definition table
TermDefinition
Varicose vein lasing procedure kitA collection of sterile devices and materials designed to perform percutaneous laser treatment of varicose veins and varicosities associated with reflux in the superficial veins of the leg. It typically contains an entry needle, a laser fibre, an introducer sheath, a catheter, a guidewire, a dilator, and connectors to facilitate connection to a laser (e.g., a diode laser) and provide a pathway for the laser energy into the section(s) of the vein to be treated. This device does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Centimeter
Needle Gauge21Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature027 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
079105071
Device count
1
Lot or batch
true
Expiration date on label
true

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