FDA.reportPublic FDA data

Shockwave Medical IVL Generator and Connector Cable

Primary DI
00195451000355
Brand
Shockwave Medical IVL Generator and Connector Cable
Company
Shockwave Medical, Inc.
Model
IVLGCCDX
Catalog number
IVLGCCDX
Device description
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic arteries.
Published
2022-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPNPercutaneous Catheter, Ultrasound
QMGShockwave Intravascular Lithotripsy System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPNPercutaneous Catheter, UltrasoundCardiovascular2
QMGShockwave Intravascular Lithotripsy SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221041000
P200039006
P200039007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221041000Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.2022-04-25PPN
P200039006Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.2021-02-12QMG
P200039007Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.2021-02-12QMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195451000355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195451000355001954510003551954510003550195451000355

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular lithotripsy system generatorAn electrically-powered device intended to produce electrical current for transmission to an appropriate catheter (not included) to perform intravascular lithotripsy in peripheral and/or coronary arteries. It typically includes controls, display, and connection cables. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
055514478
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
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
00195451001123Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterShockwave Medical, Inc.QMG2026-05-14
00195451001130Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterShockwave Medical, Inc.QMG2026-05-14
00195451001147Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterShockwave Medical, Inc.QMG2026-05-14
00195451001154Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterShockwave Medical, Inc.QMG2026-05-14
00850056723084SEISMIQ™Bolt Medical, Inc.PPN2025-11-27
00850056723008SEISMIQ™Bolt Medical, Inc.PPN2025-10-31
00850056723015SEISMIQ™Bolt Medical, Inc.PPN2025-10-31
00850056723022SEISMIQ™Bolt Medical, Inc.PPN2025-10-31
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
00195451000591Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterShockwave Medical, Inc.QMG2025-07-10
00195451000607Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterShockwave Medical, Inc.QMG2025-07-10
00195451000614Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterShockwave Medical, Inc.QMG2025-07-10
00195451000621Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterShockwave Medical, Inc.QMG2025-07-10
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
00195451000003Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterShockwave Medical, Inc.QMG2023-08-16
00195451000010Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterShockwave Medical, Inc.QMG2023-08-16
00195451000027Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterShockwave Medical, Inc.QMG2023-08-16
00195451000034Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterShockwave Medical, Inc.QMG2023-08-16
00195451000461Shockwave Medical IVL Generator and Connector CableShockwave Medical, Inc.PPN2022-12-05