RotaLink™ Advancer H80222782001A0

GUDID 08714729317739

Catheter Advancing Device

BOSTON SCIENTIFIC CORPORATION

Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered

• Primary Device ID: 08714729317739
• NIH Device Record Key: 941a19d8-3734-4a8e-b36c-6362193364e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RotaLink™ Advancer
• Version Model Number: H80222782001A0
• Catalog Number: H80222782001A0
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729317739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P900056

FDA Product Code

• MCX: CATHETER, CORONARY, ATHERECTOMY

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: 2021-05-04
• Device Publish Date: 2014-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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• 08714729042570 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042587 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042594 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729042600 - Passport Kit: 2024-04-05 Balloon Dilatation Catheter Kit
• 08714729154921 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729154969 - Passport: 2024-04-05 Balloon Dilatation Catheter
• 08714729191872 - Passport: 2024-04-05 Balloon Dilatation Catheter