Xcela

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name: Xcela FDA UDI
Generic Name: Vascular port/catheter FDA UDI
Device Name: 8F x 750mm Xcela Plastic Power Injectable Port with Pre-Attached Polyurethane Catheter FDA UDI
Model / Reference: H965451280 FDA UDI
Description: 8F x 750mm Xcela Plastic Power Injectable Port with Pre-Attached Polyurethane Catheter FDA UDI

Identifiers

Primary DI / UDI-DI: H965451280 FDA UDI
510(k) Number: K072481 FDA UDI
K073210 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

Dimensions & Sizes

Size: Length — 750 Millimeter FDA UDI
Lumen/Inner Diameter — 1.6 Millimeter FDA UDI
Outer Diameter — 2.6 Millimeter FDA UDI
Catheter Gauge — 8 French FDA UDI
Needle Gauge — 17 Gauge FDA UDI

Category: Vascular port/catheter

Xcela by Navilyst Medical, 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
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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
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

K072481 also covers:

K073210 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 d2a94f62-771b-4f49-afb1-52d15fa7adcd 37 fields · synced Jun 6, 2026