GORE® Tri-Lobe Balloon Catheter TBCM1634

GUDID 00733132619849

TRI-LOBE BALLOON CATHETER 18Fr

W. L. Gore & Associates, Inc.

Aortic endovascular implant post-dilation balloon catheter

• Primary Device ID: 00733132619849
• NIH Device Record Key: 3406f2d9-775f-4b24-bb83-ac5d725c8410
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE® Tri-Lobe Balloon Catheter
• Version Model Number: TBCM1634
• Catalog Number: TBCM1634
• Company DUNS: 967358115
• Company Name: W. L. Gore & Associates, 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com
• Phone: +1(800)528-8763
• Email: mpdcustomercare@wlgore.com

Device Dimensions

• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter
• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter
• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter
• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter
• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter
• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter
• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter
• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter
• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter
• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter
• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter
• Length: 104 Centimeter
• Catheter Gauge: 18 French
• Length: 108 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132619849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250410

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

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: 2025-06-19
• Device Publish Date: 2025-06-11

On-Brand Devices [GORE® Tri-Lobe Balloon Catheter]

• 00733132619849: TRI-LOBE BALLOON CATHETER 18Fr
• 00733132619832: TRI-LOBE BALLOON CATHETER 18Fr