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510(k) K243757

Shockwave CS Guide Catheter by Shockwave Medical, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2025
Date Received
December 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Shockwave Medical, Inc.

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  • K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Periphera (May 7, 2024)
  • K240225 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera (March 22, 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 DQY

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  • K251277 — CoraForce Microcatheter, CoraFlex Microcatheter (August 22, 2025)
  • K250972 — Primum Hydrophilic Guiding Catheter (June 29, 2025)
  • K250828 — CPS Locator 3D Plus Delivery Catheter (June 27, 2025)
  • K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313) (June 25, 2025)
  • K250492 — FlexiGo 3D Delivery Catheter (June 18, 2025)