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SHOCKWAVE MEDICAL, INC.

Last updated September 17, 2026

Information

Country: US
Address: 5403 Betsy Ross Drive, Santa Clara, CA, 95054
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3015053858
DUNS Number: —

Catalogue (90)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVL3540	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL7060	FDA UDI	Class II	Unknown
Shockwave Medical IVL Generator and Connector Cable	IVLCC	FDA UDI	Class II	Active
Shockwave Medical IVL Generator and Connector Cable	IVLGCCDC	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter	M5PIVL4060	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL6560	FDA UDI	Class II	Unknown
Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter	C2PIVL4012	FDA UDI	Class III	Active
Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter	E8IVL040080	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter	L6IVL100030	FDA UDI	Class II	Active
Lithoplasty®	M732LGCC825DX1	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVL3040	FDA UDI	Class II	Unknown
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL6060	FDA UDI	Class II	Unknown
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVL2540	FDA UDI	Class II	Active
Lithoplasty®	M732LPBC6560DX1	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL4560	FDA UDI	Class II	Unknown
Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter	E8IVL060080	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter	E8IVL025080	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter	M5PIVL7060	FDA UDI	Class II	Active
Lithoplasty®	M732LPBC6060DX1	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter	M5PIVL5560	FDA UDI	Class II	Active
Shockwave IVL System w/ Shockwave C2 Aero Coronary IVL Catheter	C2AIVL3512	FDA UDI	Class III	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL5560	FDA UDI	Class II	Unknown
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL4560	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter	C2IVL3512	FDA UDI	Class III	Active
Lithoplasty®	M732LPBC7060DX1	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVLK4040	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter	C2PIVL3012	EUDAMEDFDA UDI	Class III	Active
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVL2540	FDA UDI	Class II	Unknown
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter	K221852	FDA 510(k)	Class II	Active
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter	K203365	FDA 510(k)	Class II	Active
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System	K221041	FDA 510(k)	Class II	Active
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)	K191840	FDA 510(k)	Class II	Active
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter	K242213	FDA 510(k)	Class II	Active
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter	K240954	FDA 510(k)	Class II	Active
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable	K161384	FDA 510(k)	Class II	Active
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter	K240225	FDA 510(k)	Class II	Active
Shockwave CS Guide Catheter	K243757	FDA 510(k)	Class II	Active
Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable	K163306	FDA 510(k)	Class II	Active
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable	K180958	FDA 510(k)	Class II	Active
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter	K180454	FDA PMA	Class III	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 18, 2018	Z-3247-2018	—	terminated	Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).