Aspire RX-LP6 Aspiration Catheter 136 ARX-LP6

GUDID B090ARXLP62

ASPIRE RX-LP6 Mechanical Thrombectomy System™ and the ASPIRE Mechanical Aspirator™ Drive Unit / Pump for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

ZIEN MEDICAL TECHNOLOGIES, INC.

General-purpose syringe, single-use

• Primary Device ID: B090ARXLP62
• NIH Device Record Key: 7401fd76-daa3-455a-ae69-d3ec0299077b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspire RX-LP6 Aspiration Catheter 136
• Version Model Number: ARX-LP6
• Catalog Number: ARX-LP6
• 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	B090ARXLP60 [Primary]
HIBCC	B090ARXLP61 [Package]; Contains: B090ARXLP60; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090ARXLP62 [Package]; Contains: B090ARXLP61; Package: Shipper [9 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131998

FDA Product Code

• DXE: Catheter, Embolectomy
• QEZ: Aspiration Thrombectomy Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-09
• Device Publish Date: 2017-08-17

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