Lithoplasty®

Basic Information

• Brand Name: Lithoplasty®
• Primary DI: M732LGCC825DX1
• Version / Model: M732LGCC825DX1
• Catalog Number: M732LGCC825DX1
• Company Name: Shockwave Medical, Inc.
• Labeler DUNS: 055514478
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-09
• Public Version: 5
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 18c707e5-1585-4a47-92db-5e24b3df5afb

Device Description

The Shockwave Medical Inc. Lithoplasty® Generator provides power and exchanges data via a Connector Cable to the Lithoplasty® Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.

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: Yes
• Has Lot/Batch Number: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
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
Direct Marking	M732LG825D1	HIBCC
Primary	M732LGCC825DX1	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity