Chrysalis Intelligence · Sponsors · Shockwave Medical, Inc.

Shockwave Medical, Inc.

Santa Clara, CA, US · 8 510(k) clearances · 24 PMAs

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Total clearances
8
2021-04-22 → 2026-07-27
Last 12 months
1
Product codes
2
Most recent
2026-07-27
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PPN — — — 7 2026-07-27
DQY — — — 1 2025-05-02
Class III

PMA approvals (24)

Total PMA records
24
Originals + supplements
Distinct product codes
1
First decision
2021-02-12
Most recent
2026-06-29
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-06-29 P200039-S023 Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary IVL Catheter 30-Day Notice QMG Shockwave Intravascular Lithotripsy System Unknown
2026-06-24 P200039-S021 Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 / C2+ / C2 Aero/ C2 Aero Fly Coronary IVL Catheter 135 Review Track For 30-Day Notice QMG Shockwave Intravascular Lithotripsy System Unknown
2026-05-07 P200039-S022 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter; Sh 30-Day Notice QMG Shockwave Intravascular Lithotripsy System Unknown
2026-03-05 P200039-S020 Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary IVL Catheter 30-Day Notice QMG Shockwave Intravascular Lithotripsy System Unknown
2026-02-20 P200039-S019 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Cat Normal 180 Day Track QMG Shockwave Intravascular Lithotripsy System Unknown
2025-10-14 P200039-S018 Shockwave™ lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter 30-Day Notice QMG Shockwave Intravascular Lithotripsy System Unknown
2025-06-27 P200039-S017 Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators Real-Time Process QMG Shockwave Intravascular Lithotripsy System Unknown
2025-06-10 P200039-S015 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete Normal 180 Day Track QMG Shockwave Intravascular Lithotripsy System Unknown
2025-05-30 P200039-S016 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter 30-Day Notice QMG Shockwave Intravascular Lithotripsy System Unknown
2024-10-24 P200039-S013 Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter Normal 180 Day Track No User Fee QMG Shockwave Intravascular Lithotripsy System Unknown
2024-03-26 P200039-S014 Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter 30-Day Notice QMG Shockwave Intravascular Lithotripsy System Unknown
2023-08-17 P200039-S005 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter 135 Review Track For 30-Day Notice QMG Shockwave Intravascular Lithotripsy System Unknown
2023-06-15 P200039-S012 Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r Real-Time Process QMG Shockwave Intravascular Lithotripsy System Unknown
2023-05-08 P200039-S011 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter Normal 180 Day Track No User Fee QMG Shockwave Intravascular Lithotripsy System Unknown
2023-03-22 P200039-S010 Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters Real-Time Process QMG Shockwave Intravascular Lithotripsy System Unknown
2023-02-02 P200039-S009 Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac Normal 180 Day Track No User Fee QMG Shockwave Intravascular Lithotripsy System Unknown
2022-12-13 P200039-S008 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter Real-Time Process QMG Shockwave Intravascular Lithotripsy System Unknown
2022-09-01 P200039-S007 Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Real-Time Process QMG Shockwave Intravascular Lithotripsy System Unknown
2022-03-23 P200039-S006 Shockwave Medical, Inc. IVL Generator and Connector Cable Kit, Shockwave C2 Coronary IVL Catheter Real-Time Process QMG Shockwave Intravascular Lithotripsy System Unknown
2022-01-04 P200039-S004 Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) Real-Time Process QMG Shockwave Intravascular Lithotripsy System Unknown
2021-07-22 P200039-S003 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter 30-Day Notice QMG Shockwave Intravascular Lithotripsy System Unknown
2021-06-04 P200039-S002 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter Normal 180 Day Track No User Fee QMG Shockwave Intravascular Lithotripsy System Unknown
2021-04-09 P200039-S001 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter Normal 180 Day Track No User Fee QMG Shockwave Intravascular Lithotripsy System Unknown
2021-02-12 P200039 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter Original QMG Shockwave Intravascular Lithotripsy System Unknown
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2026-07-27 K262201 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter PPN — —
2025-05-02 K243757 Shockwave CS Guide Catheter DQY — —
2024-09-27 K242213 Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter PPN — —
2024-05-07 K240954 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter PPN — —
2024-03-22 K240225 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter PPN — —
2022-08-16 K221852 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter PPN — —
2022-04-25 K221041 Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System PPN — —
2021-04-22 K203365 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter PPN — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence