GORE Tri-Lobe Balloon Catheter BCL2645

GUDID H373BCL264536

TRI-LOBE BALLOON LARGE CATH

W. L. Gore & Associates, Inc.

Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter Aortic endovascular implant post-dilation balloon catheter

• Primary Device ID: H373BCL264536
• NIH Device Record Key: 73adb5b2-3b2c-49ba-9053-635bb908f175
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GORE Tri-Lobe Balloon Catheter
• Version Model Number: BCL2645
• Catalog Number: BCL2645
• 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
• 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
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00733132605224 [Primary]
HIBCC	H373BCL264536 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081799

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

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: 2019-08-09
• Device Publish Date: 2017-02-13

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

• H373BCM163434: TRI-LOBE BALLOON MEDIUM CATH
• H373BCL264536: TRI-LOBE BALLOON LARGE CATH