Vortex

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name: Vortex FDA UDI
Generic Name: Vascular port/catheter FDA UDI
Device Name: Vortex VX Single Titanium Port System with Attachable 7.2F x 53cm Silicone Catheter FDA UDI
Model / Reference: P5355K FDA UDI
Description: Vortex VX Single Titanium Port System with Attachable 7.2F x 53cm Silicone Catheter FDA UDI

Identifiers

Primary DI / UDI-DI: H787P5355K0 FDA UDI
510(k) Number: K010189 FDA UDI
FDA Product Code: LJT FDA UDI
GMDN Term: Vascular port/catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5965 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 18 Gauge FDA UDI
Outer Diameter — 2.4 Millimeter FDA UDI
Length — 53 Centimeter FDA UDI
Catheter Gauge — 7.2 French FDA UDI
Lumen/Inner Diameter — 1.3 Millimeter FDA UDI

Category: Vascular port/catheter

Vortex by Navilyst Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vascular port/catheter.

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PowerPort M.R.I. — Bard Access Systems, Inc. · Class II
Vital-Port — COOK INCORPORATED · Class II
PowerPort — Bard Access Systems, Inc. · Class II
Deltec — ICU MEDICAL, INC. · Class II
PowerPort ClearVUE — Bard Access Systems, Inc. · Class II

Cleared under the same submission

K010189 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Navilyst Medical, Inc.

Sources (1)

FDA UDI 16be6b75-a82b-449c-b7c7-30e00f027a79 36 fields · synced May 30, 2026