FDA.report

ENVI

Primary DI
H965481020
Brand
ENVI
Company
NAVILYST MEDICAL, INC.
Model
48-102
Device description
NEEDLE, 21G X 15CM CHIBA STYLET ECHO TIP
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
DYBINTRODUCER, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

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
H965481021PackageHIBCC10In Commercial Distribution
H965481020PrimaryHIBCC0
15051684023764SecondaryGS10

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
Length15Centimeter
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

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H787CT50STBDNFVI0BioFlo VortexCT50STBDNFVI2020-05-29
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H787CT60LPBDVI0BioFlo VortexCT60LPBDVI2020-05-29
H787CT60LPPANFNV0BioFlo VortexCT60LPPANFNV2020-05-29
H787CT60LPPANFVI0BioFlo VortexCT60LPPANFVI2020-05-29

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