Lithoplasty®

Basic Information

• Brand Name: Lithoplasty®
• Primary DI: M732LCC825D1
• Version / Model: M732LCC825D1
• Catalog Number: M732LCC825D1
• Company Name: Shockwave Medical, Inc.
• Labeler DUNS: 055514478
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-09
• Public Version: 6
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 63b5a345-4e86-4fdc-94e0-7167a55ce1c8
• Distribution End Date: 2021-02-08

Device Description

The Shockwave Medical Lithoplasty® Connector Cable is a remote actuator which connects the Lithoplasty® Generator to the Lithoplasty® Catheter and is used to activate lithotripsy energy within the balloon.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	870.1250	2
QMG	Shockwave Intravascular Lithotripsy System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
59026	Ultrasound thrombolysis system catheter, peripheral	A flexible tube designed for the percutaneous intravascular administration of high-frequency, low-energy ultrasound and drugs [e.g., tissue plasminogen activator (tPA)] for the disruption of clotted blood (i.e., a thrombus or thromboembolus) in a peripheral artery. It typically consists of a side-hole drug infusion catheter with a multi-element ultrasound core wire. The ultrasound is intended to prepare the clot by unwinding the fibrin strands, therefore enabling increased drug permeation through the clot to the vessel wall. It is a component of a system that includes a control unit to deliver the ultrasound. This is a single-use device.	No	Active
59025	Ultrasound thrombolysis system control unit	An electrically-powered device designed to generate high-frequency, low-energy ultrasound for intravascular administration to help disrupt clotted blood (i.e., a thrombus or thromboembolus). It is designed to be used with a dedicated infusion catheter for thrombolytic drug administration. The ultrasound is intended to prepare the clot by unwinding the fibrin strands, therefore enabling increased drug permeation through the clot to the vessel wall. It typically consists of a user interface, piezoelectric transducer, and one or more rechargeable battery for independent/mobile use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M732LCC825D1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]