XableCath XC-018-065B

GUDID 00853989006101

XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions.

ZIEN MEDICAL TECHNOLOGIES, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00853989006101
• NIH Device Record Key: 7cb8259b-1ec3-4dc1-8684-a53d5b98206d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XableCath
• Version Model Number: XC-018-065B
• Catalog Number: XC-018-065B
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, 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: true
• 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 Dimensions

• Catheter Length: 65 Centimeter
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter
• Guidewire Diameter: 0.018 Inch
• Catheter Length: 65 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853989006101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170041

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: 3
• Public Version Date: 2019-01-23
• Device Publish Date: 2018-09-24

On-Brand Devices [XableCath]

• 00853989006170: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006163: XableCath is an over-th-wire catheter for facilitating guide wire and catheter access in periphe
• 00853989006156: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006149: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006132: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006125: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006118: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006101: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006095: XableCath is an over the wire catheter for facilitating guide wire and catheter access to periph
• 00853989006088: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006071: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006064: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006057: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006040: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006033: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006026: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006019: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
• 00853989006002: XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph