Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera E8IVL025080

GUDID 00195451000539

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.

Shockwave Medical, Inc.

Intravascular lithotripsy system balloon catheter, peripheral
Primary Device ID00195451000539
NIH Device Record Key03ad7393-0e8b-419d-aaf1-6e35ccc2ad5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameShockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera
Version Model Number2.5x80mm
Catalog NumberE8IVL025080
Company DUNS055514478
Company NameShockwave Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com

Device Dimensions

Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French
Balloon Length80 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.054 Inch
Length150 Centimeter
Introducer Sheath Compatibilit5 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, dark, dry and away from heat

Device Identifiers

Device Issuing AgencyDevice ID
GS100195451000539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PPNPercutaneous Catheter, Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-25
Device Publish Date2024-04-17

On-Brand Devices [Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera]

00195451000577The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
00195451000560The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
00195451000553The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
00195451000546The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
00195451000539The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s

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