Cronus HP PTA Balloon Catheter

GUDID 00383790009553

OTW High Pressure Peripheral Balloon Catheter

NIPRO MEDICAL CORPORATION

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00383790009553
• NIH Device Record Key: a9bb467a-7400-48f6-bb46-1e10505d1899
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cronus HP PTA Balloon Catheter
• Version Model Number: NHP+84080
• Company DUNS: 797372554
• Company Name: NIPRO MEDICAL CORPORATION
• 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: 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

Customer Support Contacts

• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com

Device Dimensions

• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter
• Balloon Diameter: 8 Millimeter
• Catheter Length: 80 Centimeter
• Balloon Length: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383790009553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190037

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

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: 2019-11-25
• Device Publish Date: 2019-11-15

On-Brand Devices [Cronus HP PTA Balloon Catheter]

• 00383790009591: OTW High Pressure Peripheral Balloon Catheter
• 00383790009577: OTW High Pressure Peripheral Balloon Catheter
• 00383790009553: OTW High Pressure Peripheral Balloon Catheter
• 00383790009492: OTW High Pressure Peripheral Balloon Catheter
• 00383790009478: OTW High Pressure Peripheral Balloon Catheter
• 00383790009454: OTW High Pressure Peripheral Balloon Catheter
• 00383790009393: OTW High Pressure Peripheral Balloon Catheter
• 00383790009379: OTW High Pressure Peripheral Balloon Catheter
• 00383790009355: OTW High Pressure Peripheral Balloon Catheter