AccessGUDID - DEVICE: Lithoplasty® (M732LPBC6060DX1)

GUDID

Device Identifier (DI) Information

Brand Name: Lithoplasty®
Version or Model: M732LPBC6060DX1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M732LPBC6060DX1
Company Name: Shockwave Medical, Inc.

Primary DI Number: M732LPBC6060DX1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055514478 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPN	Percutaneous Catheter, Ultrasound

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry and keep away from heat.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 0.014" guidewire compatible OTW
Device Size Text, specify: 6 F introducer sheath compatible
Device Size Text, specify: 6.0x60mm balloon size
Device Size Text, specify: 0.064" folded balloon OD
Device Size Text, specify: 110cm working length

Device Record Status

Public Device Record Key: 12ba3270-cd9f-4d59-9e97-e4d68fbe643f
Public Version Date: April 21, 2021
Public Version Number: 4
DI Record Publish Date: March 09, 2017