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: 6.6F x 750mm Xcela Standard Titanium Power Injectable Port FDA UDI
Model / Reference: H965451010 FDA UDI
Description: 6.6F x 750mm Xcela Standard Titanium Power Injectable Port FDA UDI

Identifiers

Primary DI / UDI-DI: H965451010 FDA UDI
510(k) Number: 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: Lumen/Inner Diameter — 1.3 Millimeter FDA UDI
Length — 750 Millimeter FDA UDI
Catheter Gauge — 6.6 French FDA UDI
Needle Gauge — 17 Gauge FDA UDI
Outer Diameter — 2.2 Millimeter 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
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
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

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

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

Manufacturer

Manufacturer: Navilyst Medical, Inc.

Sources (1)

FDA UDI dfa99437-d983-46e2-afb9-e96e37a7c8e7 37 fields · synced Jun 8, 2026