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510(k) K240225

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter by Shockwave Medical, Inc. — Product Code PPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2024
Date Received
January 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percutaneous Catheter, Ultrasound
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.

Other clearances by Shockwave Medical, Inc.

  • K243757 — Shockwave CS Guide Catheter (May 2, 2025)
  • K242213 — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Int (September 27, 2024)
  • K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Periphera (May 7, 2024)
  • K221852 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Periphera (August 16, 2022)
  • K221041 — Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System (April 25, 2022)
  • K203365 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripher (April 22, 2021)
  • K191840 — Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connecto (August 7, 2019)
  • K180958 — Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular (July 26, 2018)
  • K180454 — Shockwave Medical Intravascular Lithotripsy (IVL) System (June 27, 2018)
  • K163306 — Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Co (December 22, 2016)

Other clearances for product code PPN

  • K250225 — Bolt Intravascular Lithotripsy (IVL) System (March 25, 2025)
  • K242213 — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Int (September 27, 2024)
  • K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Periphera (May 7, 2024)
  • K221852 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Periphera (August 16, 2022)
  • K221041 — Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System (April 25, 2022)
  • K203365 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripher (April 22, 2021)
  • K191840 — Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connecto (August 7, 2019)
  • K180958 — Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular (July 26, 2018)
  • K180454 — Shockwave Medical Intravascular Lithotripsy (IVL) System (June 27, 2018)
  • K163306 — Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Co (December 22, 2016)