FDA.reportPublic FDA data

ENVI

Primary DI
H965355170
Brand
ENVI
Company
NAVILYST MEDICAL, INC.
Model
35-517
Device description
NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 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
H965355171PackageHIBCC5In Commercial Distribution
H965355170PrimaryHIBCC0
15051684023702SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168402370215051684023702

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
H787CT50LPBANFVI0BioFlo VortexCT50LPBANFVI2020-05-29
H787CT50LPBAVI0BioFlo VortexCT50LPBAVI2020-05-29
H787CT50LPBDNFVI0BioFlo VortexCT50LPBDNFVI2020-05-29
H787CT50LPBDVI0BioFlo VortexCT50LPBDVI2020-05-29
H787CT50LTBANFVI0BioFlo VortexCT50LTBANFVI2020-05-29
H787CT50LTBAVI0BioFlo VortexCT50LTBAVI2020-05-29
H787CT50LTBDNFVI0BioFlo VortexCT50LTBDNFVI2020-05-29
H787CT50LTBDVI0BioFlo VortexCT50LTBDVI2020-05-29
H787CT50PTBANFVI0BioFlo VortexCT50PTBANFVI2020-05-29
H787CT50PTBAVI0BioFlo VortexCT50PTBAVI2020-05-29
H787CT50PTBDNFVI0BioFlo VortexCT50PTBDNFVI2020-05-29
H787CT50PTBDVI0BioFlo VortexCT50PTBDVI2020-05-29
H787CT50STBDNFVI0BioFlo VortexCT50STBDNFVI2020-05-29
H787CT50STBDVI0BioFlo VortexCT50STBDVI2020-05-29
H787CT60LPBANFVI0BioFlo VortexCT60LPBANFVI2020-05-29
H787CT60LPBAVI0BioFlo VortexCT60LPBAVI2020-05-29
H787CT60LPBDNFVI0BioFlo VortexCT60LPBDNFVI2020-05-29
H787CT60LPBDVI0BioFlo VortexCT60LPBDVI2020-05-29
H787CT60LPPANFNV0BioFlo VortexCT60LPPANFNV2020-05-29
H787CT60LPPANFVI0BioFlo VortexCT60LPPANFVI2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592468WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592475WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592499WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592505WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592512WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592529WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592536WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592543WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592550WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592567WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592598WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592604WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592611WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08