FDA.reportPublic FDA data

510(k) K240954

Device
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
Applicant
Shockwave Medical, Inc.
510(k) number
K240954
Product code
PPN
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-07
Date received
2024-04-08
Regulation
870.1250
Classification name
Percutaneous Catheter, Ultrasound
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anna Bushart
Address
5403 Betsy Ross Dr. Santa Clara CA US 95054 95054

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
K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.2025-03-25
K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.2024-09-27
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