Paxwire Occlusion Balloon System ACX101

GUDID M465ACX10106

The PaxWire Balloon Occlusion System is indicated for temporary flow occlusion in the iliofemoral artery.

Access Closure, Inc.

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided

• Primary Device ID: M465ACX10106
• NIH Device Record Key: 61062555-0d84-47fa-be89-953c527b60af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paxwire Occlusion Balloon System
• Version Model Number: ACX101
• Catalog Number: ACX101
• Company DUNS: 132286761
• Company Name: Access Closure, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M465ACX10106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143613

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-02-15
• Device Publish Date: 2016-05-09

Devices Manufactured by Access Closure, Inc.

• 10862028000434 - MYNX CONTROL: 2022-02-15 Mynx Control VCD 6F 7F
• M465ACX10106 - Paxwire Occlusion Balloon System: 2022-02-15The PaxWire Balloon Occlusion System is indicated for temporary flow occlusion in the iliofemoral artery.
• M465ACX10106 - Paxwire Occlusion Balloon System: 2022-02-15 The PaxWire Balloon Occlusion System is indicated for temporary flow occlusion in the iliofemoral artery.
• M465MX50210 - MynxGrip Vascular Closure Device (5F): 2022-02-15 MynxGrip Vascular Closure Device (5F)
• M465MX67210 - MynxGrip Vascular Closure Device (6F/7F): 2022-02-15 MynxGrip Vascular Closure Device (6F/7F)
• M465MX67400 - Mynx Ace Vascular Closure Device (6F/7F): 2022-02-15 Mynx Ace Vascular Closure Device (6F/7F)
• 10862028000427 - MYNX CONTROL: 2020-07-21 Mynx Control VCD 5F
• 20862028000400 - MYNXGRIP: 2020-04-17 MynxGrip 5F
• 20862028000417 - MYNXGRIP: 2020-04-17 MynxGrip 6F/7F