CenterFlow Molding Balloon Catheter IN20-00131

GUDID 06009880940004

The CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels. When used in its indications for use, it is a low-permissive, over-the-wire, single-use device comprised of two elongated non-compliant nylon balloons that are attached to and within a nitinol support frame. The two elongated balloons are constrained in a zigzag arrangement by the nitinol support frame. Upon inflation, this configuration enables expansion of the device head through balloon straightening, to assist the dilatation of self-expanding endoprostheses in large diameter vessels. Expansion of the zig-zag balloon configuration creates a central orifice permitting maintained hemodynamic flow during the molding procedure. The inflation lumen is 9 Fr and is made of PEBAX 72D. A co-axial PEBAX 72D guidewire lumen runs through the inflation lumen and device head and terminates into a distal polycarbonate tip. Two platinum-iridium markers provide angiographic visualization of the distal and proximal balloon edges to facilitate intravascular balloon placement prior to inflation. The catheter has a working length of 110 cm and it connects proximally to a standard Y-connector at the proximal end. The Y-connector allows for separation of two lumens - an angled luer-lock hub to inflate and deflate the balloon and a straight luer-lock hub which accepts a 0.035” guidewire. The device is deflated and inserted over the guidewire through the hemostasis valve of a transfemoral introducer sheath.

STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD

Aortic endovascular implant post-dilation balloon catheter

• Primary Device ID: 06009880940004
• NIH Device Record Key: a952731c-1d01-4b8d-83c8-769ef3f71b31
• Commercial Distribution Discontinuation: 2026-09-22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CenterFlow Molding Balloon Catheter
• Version Model Number: IN20-00131
• Catalog Number: IN20-00131
• Company DUNS: 539063485
• Company Name: STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
GS1	06009880940004 [Primary]

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

[06009880940004]

Ethylene Oxide

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[06009880940004]

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[06009880940004]

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[06009880940004]

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[06009880940004]

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[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

[06009880940004]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-09
• Device Publish Date: 2025-12-01