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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: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3015053858
DUNS Number: —

Catalogue (90)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVL3540	FDA UDI	Class II	Unknown
Shockwave Medical IVL Generator and Connector Cable	IVLGCCD	FDA UDI	Class II	Active
Lithoplasty®	M732LCC825D1	FDA UDI	Class II	Unknown
Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter	E8IVL030080	FDA UDI	Class II	Active
Shockwave IVL System w/ Shockwave C2 Aero Coronary IVL Catheter	C2AIVL4012	FDA UDI	Class III	Active
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVLK2540	FDA UDI	Class II	Active
Shockwave CS Guide Catheter	Shockwave CS Guide Catheter	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave Javelin Peripheral IVL Catheter	JVNPIVLF	FDA UDI	Class II	Active
Shockwave IVL System w/ Shockwave C2 Aero Coronary IVL Catheter	C2AIVL2512	FDA UDI	Class III	Active
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVL4040	FDA UDI	Class II	Unknown
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL4060	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter	L6IVL120030	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL3560	FDA UDI	Class II	Active
Shockwave Medical IVL Generator and Connector Cable	IVLGCC	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL6560	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL6060	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL5060	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL5060	FDA UDI	Class II	Unknown
Shockwave Medical IVL Generator and Connector Cable	IVLGCCDX	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter	M5PIVL4560	FDA UDI	Class II	Active
Lithoplasty®	M732LPBC5560DX1	FDA UDI	Class II	Active
Shockwave IVL System w/ Shockwave C2 Aero Coronary IVL Catheter	C2AIVL3012	FDA UDI	Class III	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL7060	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL3560	FDA UDI	Class II	Unknown
Lithoplasty®	M732LPBC4560DX1	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter	M5PIVL6060	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter	L6IVL090030	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVLK3040	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter	M5PIVL5060	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVL3040	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVL4040	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter	L6IVL080030	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter	C2IVL3012	FDA UDI	Class III	Active
Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter	E8IVL050080	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL4060	FDA UDI	Class II	Unknown
Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter	C2IVL2512	FDA UDI	Class III	Active
Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter	C2PIVL2512	FDA UDI	Class III	Active
Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter	M5PIVL3560	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter	C2IVL4012	FDA UDI	Class III	Active
Shockwave Medical IVL Generator and Connector Cable	IVLCC	FDA UDI	Class II	Unknown
Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter	E8IVL035080	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter	S4IVLK3540	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter	M5PIVL6560	FDA UDI	Class II	Active
Lithoplasty®	M732LPBC4060DX1	FDA UDI	Class II	Active
Lithoplasty®	M732LPBC3560DX1	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5+ Peripheral IVL Catheter	M5PIVL8060	FDA UDI	Class II	Active
Shockwave Medical IVL Generator and Connector Cable	IVLGCCD	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter	C2PIVL3512	FDA UDI	Class III	Active
Lithoplasty®	M732LPBC5060DX1	FDA UDI	Class II	Active
Shockwave IVL System with the Shockwave M5 Peripheral IVL Catheter	M5IVL5560	FDA UDI	Class II	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).