XO Constrain

GUDID B090XC2201451

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is a balloon dilation scoring/constraining catheter.

ZIEN MEDICAL TECHNOLOGIES, INC.

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: B090XC2201451
• NIH Device Record Key: 7489dbff-decd-4fa1-9289-602d06d1a0ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XO Constrain
• Version Model Number: XC2.20-145
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B090XC2201450 [Primary]
HIBCC	B090XC2201451 [Package]; Contains: B090XC2201450; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090XC2201452 [Package]; Package: Shipper [10 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: 2026-02-11
• Device Publish Date: 2026-02-03

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

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• B090XC2201451 - XO Constrain: 2026-02-11 The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is a balloon dilation scoring/constraining catheter
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