VentiV Scientific P11-090-F

GUDID B090P11090F1

The V-PULSE Mechanical Thrombectomy System is a single-use, over-the-wire (“OTW”) intravascular mechanical thrombectomy and extraction device.

ZIEN MEDICAL TECHNOLOGIES, INC.

Thrombectomy suction catheter

• Primary Device ID: B090P11090F1
• NIH Device Record Key: ae4738ed-f95d-4e4d-bebc-62556afaa94b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VentiV Scientific
• Version Model Number: P11-090-F
• Catalog Number: P11-090-F
• 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	B090P11090F0 [Primary]
HIBCC	B090P11090F1 [Package]; Contains: B090P11090F0; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090P11090F2 [Package]; Package: Shipper [5 Units]; In Commercial Distribution

FDA Product Code

• QEZ: Aspiration Thrombectomy Catheter

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: 2025-12-02
• Device Publish Date: 2025-11-24

On-Brand Devices [VentiV Scientific]

• B090P11090F1: The V-PULSE Mechanical Thrombectomy System is a single-use, over-the-wire (“OTW”) intravascu
• B090P110901: The V-PULSE Mechanical Thrombectomy System is a single-use, over-the-wire ("OTW") intravascular