FDA.reportPublic FDA data

ENVI

Primary DI
H965355150
Brand
ENVI
Company
NAVILYST MEDICAL, INC.
Model
35-515
Device description
NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 80 ROSEN-PTFE
Published
2017-08-07
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
DYBINTRODUCER, CATHETER
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GBXCATHETER, IRRIGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170775000Mini Stick ENVI Non-Vascular Introducer KitAngioDynamics, Inc.2017-07-19DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965355151PackageHIBCC5In Commercial Distribution
H965355150PrimaryHIBCC0
15051684023689SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168402368915051684023689

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Length20Centimeter
Lumen/Inner Diameter0.5Millimeter
Needle Gauge21Gauge

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
809699023
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787471430Celerity47-1432015-10-19
H787LG191005LifeguardLG-19-1002016-09-20
H787LG19755LifeguardLG-19-752016-09-20
H787LG201005LifeguardLG-20-1002016-09-20
H787LG201505LifeguardLG-20-1502016-09-20
H787LG20505LifeguardLG-20-502016-09-20
H787LG20755LifeguardLG-20-752016-09-20
H787LG221005LifeguardLG-22-1002016-09-20
H787LG22505LifeguardLG-22-502016-09-20
H787LG22755LifeguardLG-22-752016-09-20
H787LPS30045LifeportLPS 30042016-09-20
H787LPS30055LifeportLPS 30052016-09-20
H787LPS30065LifeportLPS 30062016-09-20
H787LPS30075LifeportLPS 30072016-09-20
H787LPS30085LifeportLPS 30082016-09-20
H787LPS30095LifeportLPS 30092016-09-20
H787LPS30175LifeportLPS 30172016-09-20
H787LPS30235LifeportLPS 30232016-09-20
H787LPS30255LifeportLPS 30252016-09-20
H787CT50LPBANFVI0BioFlo VortexCT50LPBANFVI2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-20
09347144017596Metier MedicalMETIER MEDICAL LTDGAA2026-10-19
00860015723901NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723918NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723925NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723932NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00821329003455GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00821329003462GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
10198956491298CARDINAL HEALTHCardinal Health 200, LLCGAA2026-10-12
00817295020138InradInradGAA2026-10-09
00817295020145InradInradGAA2026-10-09
00817295020183InradInradGAA2026-10-09
00817295020190InradInradGAA2026-10-09
00817295020206InradInradGAA2026-10-09
00817295020213InradInradGAA2026-10-09
00817295020220InradInradGAA2026-10-09
00817295020237InradInradGAA2026-10-09
00817295020244InradInradGAA2026-10-09
00817295020251InradInradGAA2026-10-09
00817295020268InradInradGAA2026-10-09
00817295020275InradInradGAA2026-10-09
00817295020282InradInradGAA2026-10-09
00817295020299InradInradGAA2026-10-09
00817295020305InradInradGAA2026-10-09
00817295020312InradInradGAA2026-10-09
00817295020329InradInradGAA2026-10-09
00817295020336InradInradGAA2026-10-09
00817295020343InradInradGAA2026-10-09
00817295020350InradInradGAA2026-10-09
00817295020367InradInradGAA2026-10-09