FDA.reportPublic FDA data

Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter

Primary DI
00195451000072
Brand
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter
Company
Shockwave Medical, Inc.
Model
S4IVL4040
Catalog number
S4IVL4040
Device description
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Published
2021-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPNPercutaneous Catheter, Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPNPercutaneous Catheter, UltrasoundCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191840000Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)Shockwave Medical, Inc.2019-08-07PPN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M732S4IVL40400PreviousHIBCC0
00195451000072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195451000072001954510000721954510000720195451000072

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound thrombolysis system catheter, peripheralA sterile 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter4Millimeter
Balloon Length40Millimeter
Balloon Nominal (Inflation) Pr6Atmosphere
Balloon Proximal Outer Diamete0.054Inch
Balloon Rated Burst Pressure10Atmosphere
Catheter Working Length135Centimeter
Guidewire Diameter0.014Inch
Introducer Sheath Compatibilit5French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and keep away from heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-775-4846cs@shockwavemedical.com

Regulatory Flags#

DUNS number
055514478
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195451000003Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL2512C2PIVL25122023-08-16
00195451000010Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL3012C2PIVL30122023-08-16
00195451000027Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL3512C2PIVL35122023-08-16
00195451000034Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL4012C2PIVL40122023-08-16
00195451001123Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL2512C2AFIVL25122026-05-14
00195451001130Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL3012C2AFIVL30122026-05-14
00195451001147Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL3512C2AFIVL35122026-05-14
00195451001154Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL4012C2AFIVL40122026-05-14
00195451000799Shockwave IVL System with the Shockwave Javelin Peripheral IVL CatheterJVNPIVLFJVNPIVLF2024-10-09
00195451000591Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterC2AIVL2512C2AIVL25122025-07-10
00195451000607Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterC2AIVL3012C2AIVL30122025-07-10
00195451000614Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterC2AIVL3512C2AIVL35122025-07-10
00195451000621Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterC2AIVL4012C2AIVL40122025-07-10
00195451000539Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL025080E8IVL0250802024-04-17
00195451000546Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL030080E8IVL0300802024-04-17
00195451000553Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL035080E8IVL0350802024-04-17
00195451000560Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL040080E8IVL0400802024-04-17
00195451000577Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL050080E8IVL0500802024-04-17
00195451000584Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL060080E8IVL0600802024-04-17
00195451000386Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterL6IVL080030L6IVL0800302022-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056723084SEISMIQ™Bolt Medical, Inc.PPN2025-11-27
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00850056723039SEISMIQ™Bolt Medical, Inc.PPN2025-10-31
00850056723046SEISMIQ™Bolt Medical, Inc.PPN2025-10-31
00850056723053SEISMIQ™Bolt Medical, Inc.PPN2025-10-31
00850056723060SEISMIQ™Bolt Medical, Inc.PPN2025-10-31
00850056723077SEISMIQ™Bolt Medical, Inc.PPN2025-10-31
00850056723091SEISMIQ™Bolt Medical, Inc.PPN2025-10-31
00195451000799Shockwave IVL System with the Shockwave Javelin Peripheral IVL CatheterShockwave Medical, Inc.PPN2024-10-09
00195451000539Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.PPN2024-04-17
00195451000546Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.PPN2024-04-17
00195451000553Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.PPN2024-04-17
00195451000560Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.PPN2024-04-17
00195451000577Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.PPN2024-04-17
00195451000584Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.PPN2024-04-17
00195451000355Shockwave Medical IVL Generator and Connector CableShockwave Medical, Inc.PPN2022-12-22
00195451000461Shockwave Medical IVL Generator and Connector CableShockwave Medical, Inc.PPN2022-12-05
00195451000386Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.PPN2022-10-24
00195451000393Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.PPN2022-10-24
00195451000409Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.PPN2022-10-24
00195451000416Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.PPN2022-10-24
00195451000317Shockwave IVL System with the Shockwave S4 Peripheral IVL CatheterShockwave Medical, Inc.PPN2021-06-08
00195451000324Shockwave IVL System with the Shockwave S4 Peripheral IVL CatheterShockwave Medical, Inc.PPN2021-06-08
00195451000331Shockwave IVL System with the Shockwave S4 Peripheral IVL CatheterShockwave Medical, Inc.PPN2021-06-08
00195451000348Shockwave IVL System with the Shockwave S4 Peripheral IVL CatheterShockwave Medical, Inc.PPN2021-06-08
00195451000201Shockwave IVL System with the Shockwave M5+ Peripheral IVL CatheterShockwave Medical, Inc.PPN2021-05-11
00195451000218Shockwave IVL System with the Shockwave M5+ Peripheral IVL CatheterShockwave Medical, Inc.PPN2021-05-11
00195451000225Shockwave IVL System with the Shockwave M5+ Peripheral IVL CatheterShockwave Medical, Inc.PPN2021-05-11