XO Score S6.50-065

GUDID B090S6500651

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.

ZIEN MEDICAL TECHNOLOGIES, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: B090S6500651
• NIH Device Record Key: 583906e5-e78f-481b-b78e-c26aee7e030e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XO Score
• Version Model Number: S6.50-065
• Catalog Number: S6.50-065
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Working Length: 65 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Gauge: 6.4 French
• Device Size Text, specify: 0
• Catheter Working Length: 65 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Gauge: 6.4 French
• Device Size Text, specify: 0
• Catheter Working Length: 65 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Gauge: 6.4 French
• Device Size Text, specify: 0
• Catheter Working Length: 65 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Gauge: 6.4 French
• Device Size Text, specify: 0
• Catheter Working Length: 65 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Gauge: 6.4 French
• Device Size Text, specify: 0
• Catheter Working Length: 65 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Gauge: 6.4 French
• Device Size Text, specify: 0
• Catheter Working Length: 65 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Gauge: 6.4 French
• Device Size Text, specify: 0
• Catheter Working Length: 65 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Gauge: 6.4 French
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B090S6500650 [Primary]
HIBCC	B090S6500651 [Package]; Contains: B090S6500650; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090S6500652 [Package]; Package: Shipper [5 Units]; In Commercial Distribution

FDA Product Code

• PNO: Catheter, Percutaneous, Cutting/Scoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-28
• Device Publish Date: 2022-06-20

On-Brand Devices [XO Score]

• B090S6500651: The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in co
• B090S6250650: The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in co