Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary C2PIVL3012

GUDID 00195451000010

The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2+ Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2+ is compatible with a 5F guiding catheter and extensions, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.

Shockwave Medical, Inc.

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• Primary Device ID: 00195451000010
• NIH Device Record Key: a5a632cb-4520-4945-ac5a-96241629f81c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary
• Version Model Number: 3.0x12mm
• Catalog Number: C2PIVL3012
• Company DUNS: 055514478
• Company Name: Shockwave Medical, 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

Customer Support Contacts

• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com

Device Dimensions

• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French
• Balloon Length: 12 Centimeter
• Balloon Diameter: 3 Millimeter
• Balloon Proximal Outer Diamete: 0.045 Inch
• Length: 138 Centimeter
• Guidewire Compatibility: 5 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195451000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200039

FDA Product Code

• QMG: Shockwave Intravascular Lithotripsy System

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: 2023-08-24
• Device Publish Date: 2023-08-16

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• 00195451000003: The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through th