Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter

GUDID 05391525787503

018 Advance Serenity 7x220, 135cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 05391525787503
• NIH Device Record Key: c67c1502-bad0-4d4f-8a01-241d40e9855b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter
• Version Model Number: SER18-135-70-220
• Company DUNS: 985021909
• Company Name: CREAGH MEDICAL LIMITED
• 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

Device Dimensions

• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 220 Millimeter
• Catheter Working Length: 135 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525787503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242419

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: 2025-03-24
• Device Publish Date: 2025-03-14

On-Brand Devices [Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter]

• 05391525787503: 018 Advance Serenity 7x220, 135cm
• 05391525787497: 018 Advance Serenity 6x220, 135cm
• 05391525787480: 018 Advance Serenity 5x220, 135cm