FDA.report

ENVI

Primary DI
H965355110
Brand
ENVI
Company
NAVILYST MEDICAL, INC.
Model
35-510
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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GBXCATHETER, IRRIGATION

Product Code Classifications

CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Premarket Submissions

SubmissionSupplement
K170775000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H965355111PackageHIBCC5In Commercial Distribution
H965355110PrimaryHIBCC0
15051684023641SecondaryGS10

GMDN Terms

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

TypeValueUnit
Catheter Gauge6French
Length20Centimeter
Lumen/Inner Diameter0.5Millimeter
Needle Gauge21Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags

DUNS number
809699023
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
false
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 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 DIBrandCompanyProduct codePublished
00822045001503SAM ThoraSite®SAM Medical ProductsGBX2025-12-12
20885380182430JACKSON-PRATTCardinal Health 200, LLCGBX2025-09-12
20885380182508CARDINAL HEALTHCardinal Health 200, LLCGBX2025-09-12
34026704933373PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-08
34026704933380PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-02
24026704933406PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-02
10884450581008ReSolve®Merit Medical Systems, Inc.GBX2025-05-23
10661392032009LSL HEALTHCARELSL Industries, LLCGBX2025-05-16
10884450779900ReSolve®Merit Medical Systems, Inc.GBX2025-05-13
00840456205891JMUJMU DENTAL, INCGBX2025-05-02
24026704933345PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933352PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933413PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933468PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933472PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933489PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
24026704933499PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933502PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933519PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933526PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933311PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933328PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933338PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933366PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933390PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933420PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933437PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933444PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933458PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
10884450719937ReSolve Mini™Merit Medical Systems, Inc.GBX2025-03-15