Aspire Max 5 Aspiration Catheter 55cm A5-055

GUDID B090A50552

ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

ZIEN MEDICAL TECHNOLOGIES, INC.

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: B090A50552
• NIH Device Record Key: df3d7d06-0fb2-4e4f-9f23-04af8f6fe967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspire Max 5 Aspiration Catheter 55cm
• Version Model Number: A5-055
• Catalog Number: A5-055
• 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	B090A50550 [Primary]
HIBCC	B090A50551 [Package]; Contains: B090A50550; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090A50552 [Package]; Contains: B090A50551; Package: Shipper [9 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113757

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-12
• Device Publish Date: 2017-08-17

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

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