FDA.reportPublic FDA data

510(k) K250225

Device
Bolt Intravascular Lithotripsy (IVL) System
Applicant
Bolt Medical, Inc.
510(k) number
K250225
Product code
PPN
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-25
Date received
2025-01-27
Regulation
870.1250
Classification name
Percutaneous Catheter, Ultrasound
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Stephanie Onstot
Address
2131 Faraday Ave. Carlsbad CA US 92008 92008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PPN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.2024-09-27
K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.2024-05-07
K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.2024-03-22
K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.2022-08-16
K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.2022-04-25
K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL CatheterShockwave Medical, Inc.2021-04-22
K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)Shockwave Medical, Inc.2019-08-07
K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector CableShockwave Medical, Inc.2018-07-26
K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.2018-06-27
K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector CableShockwave Medical, Inc.2016-12-22
K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector CableShockwave Medical, Inc.2016-09-14