FDA.reportPublic FDA data

SEISMIQ™

Primary DI
00850056723091
Brand
SEISMIQ™
Company
Bolt Medical, Inc.
Model
FG-006921
Catalog number
FG-006921
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
OTC
false
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
00850056723091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056723091008500567230918500567230910850056723091

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 Diameter8Millimeter
Balloon Length60Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117202600
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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
00195451000799Javelin Peripheral IVL CatheterShockwave Medical, Inc.PPN2024-10-09
00195451000539Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 PeripheraShockwave Medical, Inc.PPN2024-04-17
00195451000546Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 PeripheraShockwave Medical, Inc.PPN2024-04-17
00195451000553Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 PeripheraShockwave Medical, Inc.PPN2024-04-17
00195451000560Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 PeripheraShockwave Medical, Inc.PPN2024-04-17
00195451000577Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 PeripheraShockwave Medical, Inc.PPN2024-04-17
00195451000584 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 PeripherShockwave Medical, Inc.PPN2024-04-17
00195451000355Shockwave Intravascular Lithotripsy (IVL) Generator and Connector CableShockwave Medical, Inc.PPN2022-12-22
00195451000461Shockwave Intravascular Lithotripsy (IVL) Generator and Connector CableShockwave Medical, Inc.PPN2022-12-05
00195451000386Shockwave Medical L6 Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.PPN2022-10-24
00195451000393Shockwave Medical L6 Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.PPN2022-10-24
00195451000409Shockwave Medical L6 Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.PPN2022-10-24
00195451000416Shockwave Medical L6 Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.PPN2022-10-24
00195451000294Shockwave Intravascular Lithotripsy (IVL) Generator and Connector CableShockwave Medical, Inc.PPN2021-02-11
00195451000300Shockwave Intravascular Lithotripsy (IVL) Connector CableShockwave Medical, Inc.PPN2021-02-11
00195451000041Shockwave S4Shockwave Medical, Inc.PPN2021-02-04
00195451000058Shockwave S4Shockwave Medical, Inc.PPN2021-02-04
00195451000065Shockwave S4Shockwave Medical, Inc.PPN2021-02-04
00195451000072Shockwave S4Shockwave Medical, Inc.PPN2021-02-04
00195451000126Shockwave M5Shockwave Medical, Inc.PPN2021-02-04
00195451000133Shockwave M5Shockwave Medical, Inc.PPN2021-02-04