Shockwave Intravascular Lithotripsy (IVL) Connector Cable IVLCC

GUDID 00195451000300

The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate lithotripsy energy within the IVL balloon catheter.

Shockwave Medical, Inc.

Ultrasonic lithotripsy system transducer, single-use

• Primary Device ID: 00195451000300
• NIH Device Record Key: 421d8bdf-9e78-47c3-b2b9-fb74f6e34e50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shockwave Intravascular Lithotripsy (IVL) Connector Cable
• Version Model Number: 825D
• Catalog Number: IVLCC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00195451000300 [Primary]
HIBCC	M732IVLCC0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191840

FDA Product Code

• PPN: Percutaneous Catheter, Ultrasound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-19
• Device Publish Date: 2021-02-11

Devices Manufactured by Shockwave Medical, Inc.

• 00195451000799 - Javelin Peripheral IVL Catheter: 2024-10-17 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
• 00195451000539 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera: 2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
• 00195451000546 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera: 2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
• 00195451000553 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera: 2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
• 00195451000560 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera: 2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
• 00195451000577 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera: 2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
• 00195451000584 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripher: 2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
• 00195451000003 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary: 2023-08-24 The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of th