FDA.reportPublic FDA data

SEISMIQ™

Primary DI
00850056723084
Brand
SEISMIQ™
Company
Bolt Medical, Inc.
Model
FG-010978
Catalog number
FG-010978
Device description
Intravascular Lithotripsy Console
Published
2025-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
PPNPercutaneous Catheter, Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPNPercutaneous Catheter, UltrasoundCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056723084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056723084008500567230848500567230840850056723084

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117202600
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056723008SEISMIQ™FG-006912FG-0069122025-10-31
00850056723015SEISMIQ™FG-006913FG-0069132025-10-31
00850056723022SEISMIQ™FG-006914FG-0069142025-10-31
00850056723039SEISMIQ™FG-006915FG-0069152025-10-31
00850056723046SEISMIQ™FG-006916FG-0069162025-10-31
00850056723053SEISMIQ™FG-006917FG-0069172025-10-31
00850056723060SEISMIQ™FG-006918FG-0069182025-10-31
00850056723077SEISMIQ™FG-006919FG-0069192025-10-31
00850056723091SEISMIQ™FG-006921FG-0069212025-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00195451000232Shockwave IVL System with the Shockwave M5+ Peripheral IVL CatheterShockwave Medical, Inc.PPN2021-05-11