Smart Port CT

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc

Identity

Trade Name: Smart Port CT FDA UDI
Generic Name: Vascular port/catheter FDA UDI
Device Name: Smart Port CT Single Titanium Port System with Attachable 9.6F x 66cm Silicone Catheter and 10 F Introducer Kit (with Non-Filled Suture Holes) FDA UDI
Model / Reference: H787CT96STSDNF0 FDA UDI
Description: Smart Port CT Single Titanium Port System with Attachable 9.6F x 66cm Silicone Catheter and 10 F Introducer Kit (with Non-Filled Suture Holes) FDA UDI

Identifiers

Catalog Number: CT96STSD-NF FDA UDI
Primary DI / UDI-DI: 15051684018074 FDA UDI
510(k) Number: K062414 FDA UDI
FDA Product Code: FPA FDA UDI
LJT FDA UDI
GMDN Term: Vascular port/catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5440 FDA UDI
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: Lumen/Inner Diameter — 1.6 Millimeter FDA UDI
Catheter Gauge — 9.6 French FDA UDI
Length — 66 Centimeter FDA UDI
Outer Diameter — 3.2 Millimeter FDA UDI

Category: Vascular port/catheter

Smart Port CT by Angiodynamics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular port/catheter.

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

Cleared under the same submission

K062414 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Angiodynamics, Inc

Sources (1)

FDA UDI cbd8a89a-056b-43e7-a7da-ff5e33e1283a 37 fields · synced Jun 20, 2026