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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 7.5F x 66cm Silicone Catheter and 8F Introducer Kit (with Non-Filled Suture Holes) FDA UDI
Model / Reference
CT75STSD-NF FDA UDI
Description
Smart Port CT Single Titanium Port System with Attachable 7.5F x 66cm Silicone Catheter and 8F Introducer Kit (with Non-Filled Suture Holes) FDA UDI

Identifiers

Primary DI / UDI-DI
H787CT75STSDNF0 FDA UDI
510(k) Number
K062414 FDA UDI
FDA Product Code
LJT FDA UDI
FPA FDA UDI
GMDN Term
Vascular port/catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5965 FDA UDI
880.5440 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 2.5 Millimeter FDA UDI
Lumen/Inner Diameter — 1.4 Millimeter FDA UDI
Length — 66 Centimeter FDA UDI
Catheter Gauge — 7.5 French FDA UDI

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

Cleared under the same submission

K062414 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Angiodynamics, Inc.

Sources (1)

  • FDA UDI 3b313f61-0ecf-4da0-ba95-8a1792b42b5b 37 fields · synced Jun 8, 2026