FDA.reportPublic FDA data

SEISMIQ™

Primary DI
00850056723008
Brand
SEISMIQ™
Company
Bolt Medical, Inc.
Model
FG-006912
Catalog number
FG-006912
Device description
Intravascular Lithotripsy Catheter
Published
2025-10-31
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

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
00850056723008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056723008008500567230088500567230080850056723008

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular lithotripsy system catheter, balloon, peripheralAn electrically-powered, flexible tube, with an inflatable balloon at its distal end, intended to be introduced into a peripheral artery (excludes coronary and cerebral arteries) to transmit ultrasonic acoustic pressure waves circumferentially for the modification and fragmentation of calcified plaque, to improve vessel compliance. It includes transducers intended to convert electrical to ultrasonic energy, and a balloon to facilitate energy transmission and vessel dilation. It is used in conjunction with a dedicated control unit/generator (not included). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter3.5Millimeter
Balloon Length60Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117202600
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850056723084SEISMIQ™FG-010978FG-0109782025-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056723084SEISMIQ™Bolt Medical, Inc.PPN2025-11-27
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