Atlas FDA

PPN

13 FDA 510(k) clearances · Product code

56 daysmedian time to decision
127 days90th percentile
13clearances measured

FDA profile

Official device name
Percutaneous Catheter, Ultrasound
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Medical specialty
Cardiovascular
FDA definition
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Adverse events (MAUDE)
2021: 18 · 2022: 35 · 2023: 30 · 2024: 45 · 2025: 44 · 2026: 40
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (K262201)Shockwave Medical, Inc.2026-07-27
Bolt Intravascular Lithotripsy (IVL) System (K250225)Bolt Medical, Inc.2025-03-25
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter (K242213)Shockwave Medical, Inc.2024-09-27
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (K240954)Shockwave Medical, Inc.2024-05-07
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter (K240225)Shockwave Medical, Inc.2024-03-22
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (K221852)Shockwave Medical, Inc.2022-08-16
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System (K221041)Shockwave Medical, Inc.2022-04-25
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter (K203365)Shockwave Medical, Inc.2021-04-22
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) (K191840)Shockwave Medical, Inc.2019-08-07
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable (K180958)Shockwave Medical, Inc.2018-07-26
Shockwave Medical Intravascular Lithotripsy (IVL) System (K180454)Shockwave Medical, Inc.2018-06-27
Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable (K163306)Shockwave Medical, Inc.2016-12-22
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable (K161384)Shockwave Medical, Inc.2016-09-14

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Every clearance here is in the API, with alerts when new ones post.