Cruzar Medsystems Inc.

GUDID 00860554000327

The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneous use. The Houdini Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.

CRUZAR MEDSYSTEMS INC

Vascular guide-catheter, single-use

• Primary Device ID: 00860554000327
• NIH Device Record Key: 7d15aa52-802d-49f8-879b-b054c9386d3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cruzar Medsystems Inc.
• Version Model Number: CM-3700
• Company DUNS: 080338871
• Company Name: CRUZAR MEDSYSTEMS 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: 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

Device Dimensions

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Pressure: 176 Pound per Square Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860554000327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151896

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: 2019-01-23
• Device Publish Date: 2016-08-26

On-Brand Devices [Cruzar Medsystems Inc.]

• 00860554000396: The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneou
• 00860554000365: The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneou
• 00860554000358: The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneou
• 00860554000334: The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneou
• 00860554000327: The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneou