XO Score

FDA UDI

Class II (US FDA UDI)

by ZIEN Medical Technologies, LLC

Identity

Trade Name: XO Score FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature. FDA UDI
Model / Reference: S6.25-065 FDA UDI
Description: The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature. FDA UDI

Identifiers

Catalog Number: S6.25-065 FDA UDI
Primary DI / UDI-DI: B090S6250650 FDA UDI
FDA Product Code: PNO FDA UDI
GMDN Term: Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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: Catheter Working Length — 65 Centimeter FDA UDI
Introducer Sheath Compatibility — 7 French FDA UDI
Catheter Gauge — 6.4 French FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

XO Score by ZIEN Medical Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: ZIEN Medical Technologies, LLC

Sources (1)

FDA UDI 66515882-d94b-4898-95a0-f1b836b38c53 35 fields · synced Jun 1, 2026