GoBack Crossing Catheter

Basic Information

• Brand Name: GoBack Crossing Catheter
• Primary DI: 07290017837116
• Version / Model: GB 600-US 018P 80L
• Company Name: UPSTREAM PERIPHERAL TECHNOLOGIES LTD
• Labeler DUNS: 649244308
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-19
• Public Version: 2
• Public Version Date: 2023-01-02
• Public Version Status: Update
• Public Device Record Key: 58e02064-8895-4bf8-b952-3153b9bd2025
• Distribution End Date: 2022-12-31

Device Description

The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures. The Upstream™ GB Crossing Catheter is intended to be used in conjunction with a steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The Upstream GoBack Crossing Catheter have outer diameter of 4FRr (1.4mm) or 2.9Fr (0.96mm), accommodate 0.018” or 0.014” guidewires accordingly, and both diameters have effective length of 80cm or 120 cm.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017837116	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius