Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera E8IVL035080

GUDID 00195451000553

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The Shockwave E8 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

Shockwave Medical, Inc.

Intravascular lithotripsy system balloon catheter, peripheral

• Primary Device ID: 00195451000553
• NIH Device Record Key: bba26826-422b-4f81-9548-9b528b7ee9ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera
• Version Model Number: 3.5x80mm
• Catalog Number: E8IVL035080
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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
• 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
• 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: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter
• Balloon Length: 80 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Proximal Outer Diamete: 0.056 Inch
• Introducer Sheath Compatibilit: 5 French
• Length: 150 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight, dark, dry and away from heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195451000553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240225

FDA Product Code

• PPN: Percutaneous Catheter, Ultrasound

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: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera]

• 00195451000577: The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
• 00195451000560: The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
• 00195451000553: The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
• 00195451000546: The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
• 00195451000539: The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s