Lithoplasty®

Basic Information

• Brand Name: Lithoplasty®
• Primary DI: M732LPBC5560DX1
• Version / Model: M732LPBC5560DX1
• Catalog Number: M732LPBC5560DX1
• 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: 4
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 9c4398bb-51ef-4818-a5fa-c40baa3ab5c6

Device Description

The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilation of otherwise difficult to treat calcified stenosis of the peripheral vasculature.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M732LPBC5560DX1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.014" guidewire compatible OTW
Device Size Text, specify			6 F introducer sheath compatible
Device Size Text, specify			5.5x60mm balloon size
Device Size Text, specify			0.064" folded balloon OD
Device Size Text, specify			110cm working length

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and keep away from heat.