AccessGUDID - DEVICE: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera (00195451000577)

GUDID

Device Identifier (DI) Information

Brand Name: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera
Version or Model: 5.0x80mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E8IVL050080
Company Name: Shockwave Medical, Inc.

Primary DI Number: 00195451000577
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055514478 *Terms of Use

Device Description: The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The Shockwave E8 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

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":	Yes
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?
66729	Intravascular lithotripsy system balloon catheter, peripheral	An electrically-powered, flexible tube intended to be introduced into a peripheral artery stiffened by a highly calcified atheromatous plaque, to transmit ultrasound (US) waves [e.g., acoustic pressure pulses] for the disruption of the plaque to improve vessel compliance. It is used in conjunction with a dedicated control unit/generator (not included) and includes transducers intended to convert electrical energy to ultrasound and an inflatable balloon at its distal end to facilitate energy transmission and dilation of the vessel. This is a single-use device.	Active	false
12535	Medical equipment/instrument drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPN	Percutaneous Catheter, Ultrasound
OEZ	Cardiovascular Procedure Kit
JAA	System, X-Ray, Fluoroscopic, Image-Intensified

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240225	000

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 away from sunlight, dark, dry and away from heat

Clinically Relevant Size

[?]

Size Type Text
Balloon Length: 80 Millimeter
Balloon Diameter: 5.0 Millimeter
Balloon Proximal Outer Diameter (OD): 0.068 Inch
Length: 150 Centimeter
Introducer Sheath Compatibility: 6 French

Device Record Status

Public Device Record Key: d54cfdb3-75d2-4463-aa8e-bf012c8324ec
Public Version Date: September 11, 2024
Public Version Number: 3
DI Record Publish Date: April 17, 2024