Clearance details

Applicant: Shockwave Medical, Inc.
Product code: Code PPN
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2018-02-20
Decision date: 2018-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Recent devices under product code PPN

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K260246 — SEISMIQ Intravascular Lithotripsy System2026-08-24
K262201 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter2026-07-27
K250225 — Bolt Intravascular Lithotripsy (IVL) System2025-03-25
K242213 — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter2024-09-27
K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter2024-05-07

More clearances from Shockwave Medical, Inc.

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Adverse events under product code PPN

product code PPN

Death: 16
Total: 16

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K180454

K-number listed on FDA's recall record

Z-3247-2018 — The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral Intravascular Lithotripsy Catheter, CE 0086, STERILE R, Manufacturer: Shockwave Medical, Inc. 48501 Warm Springs Blvd. Ste. 108, Fremont, CA 94539Class II·Terminated·Shockwave Medical, Inc.·20180718

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180454.