FDA.report

Vortex

Primary DI
H787SSDX14I0
Brand
Vortex
Company
NAVILYST MEDICAL, INC.
Model
SSDX-14-I
Device description
Vortex TR Single Titanium Port System with Attachable 7.5F x 70cm Silicone Catheter
Published
2018-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
LJTPort & Catheter, Implanted, Subcutaneous, IntravascularGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K951814000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K951814000TRIUMPH-1 PORTHorizon Medical Products, Inc.1995-08-29LJT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H787SSDX14I0PrimaryHIBCC0
15051684018456SecondaryGS10

GMDN Terms

TermDefinition
Infusion/injection port, implantableA sterile metallic and/or non-metallic device intended to be implanted subcutaneously in a patient for the short- or long-term delivery of fluids or medications to the vascular system or other anatomical region. The device consists of a housing with a self-sealing septum and a catheter connection mechanism. The device may be implanted in various anatomical locations. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge7.5French
Length70Centimeter
Lumen/Inner Diameter1.4Millimeter
Needle Gauge18Gauge
Outer Diameter2.5Millimeter

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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