Shockwave Medical Inc

FDA Filings

This page includes the latest FDA filings for Shockwave Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQSWAVDUNS 055514478
FDA Registration(s)
Registration Number3015053858
FEI Number3015053858
NameSHOCKWAVE MEDICAL, INC.
Owner & OperatorShockwave Medical, Inc.
Contact Address5403 Betsy Ross Drive
Santa Clara CA 95054 US
Official Correspondent
  • Peter Nowakowski
  • 001-408-5502609-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5403 Betsy Ross Drive
Santa Clara, CA 95054 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
Shockwave Medical, Inc.
Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL40122021-02-25
Shockwave Medical, Inc.
Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL35122021-02-25
Shockwave Medical, Inc.
Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL30122021-02-25
Shockwave Medical, Inc.
Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL25122021-02-25
Shockwave Medical, Inc.
Shockwave Intravascular Lithotripsy (IVL) Connector Cable IVLCC2021-02-19
Shockwave Medical, Inc.
Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable IVLGCCD2021-02-19
Shockwave Medical, Inc.
Shockwave Intravascular Litbotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter2021-02-12
Shockwave Medical, Inc.
Shockwave M5 M5IVL70602021-02-12
Shockwave Medical, Inc.
Shockwave M5 M5IVL65602021-02-12
Shockwave Medical, Inc.
Shockwave M5 M5IVL60602021-02-12
Shockwave Medical, Inc.
Shockwave M5 M5IVL55602021-02-12
Shockwave Medical, Inc.
Shockwave M5 M5IVL50602021-02-12
Shockwave Medical, Inc.
Shockwave M5 M5IVL45602021-02-12
Shockwave Medical, Inc.
Shockwave M5 M5IVL40602021-02-12
Shockwave Medical, Inc.
Shockwave M5 M5IVL35602021-02-12
Shockwave Medical, Inc.
Shockwave S4 S4IVL40402021-02-12
Shockwave Medical, Inc.
Shockwave S4 S4IVL35402021-02-12
Shockwave Medical, Inc.
Shockwave S4 S4IVL30402021-02-12
Shockwave Medical, Inc.
Shockwave S4 S4IVL25402021-02-12
Shockwave Medical, Inc.
Shockwave S4 S4IVL40402021-01-14
Shockwave Medical, Inc.
Shockwave S4 S4IVL35402021-01-14
Shockwave Medical, Inc.
Shockwave S4 S4IVL30402021-01-14
Shockwave Medical, Inc.
Shockwave S4 S4IVL25402021-01-14
Shockwave Medical, Inc.
Shockwave M5 M5IVL70602021-01-14
Shockwave Medical, Inc.
Shockwave M5 M5IVL65602021-01-14
Shockwave Medical, Inc.
Shockwave M5 M5IVL60602021-01-14
Shockwave Medical, Inc.
Shockwave M5 M5IVL55602021-01-14
Shockwave Medical, Inc.
Shockwave M5 M5IVL50602021-01-14
Shockwave Medical, Inc.
Shockwave M5 M5IVL45602021-01-14
Shockwave Medical, Inc.
Shockwave M5 M5IVL40602021-01-14
Shockwave Medical, Inc.
Shockwave M5 M5IVL35602021-01-14
Shockwave Medical, Inc.
Lithoplasty® M732LPBC7060DX12021-01-14
Shockwave Medical, Inc.
Lithoplasty® M732LPBC6560DX12021-01-14
Shockwave Medical, Inc.
Lithoplasty® M732LPBC6060DX12021-01-14
Shockwave Medical, Inc.
Lithoplasty® M732LPBC5560DX12021-01-14
Shockwave Medical, Inc.
Lithoplasty® M732LPBC5060DX12021-01-14
Shockwave Medical, Inc.
Lithoplasty® M732LPBC4560DX12021-01-14
Shockwave Medical, Inc.
Lithoplasty® M732LPBC4060DX12021-01-14
Shockwave Medical, Inc.
Lithoplasty® M732LPBC3560DX12021-01-14
Shockwave Medical, Inc.
Lithoplasty® M732LGCC825DX12021-01-14
Shockwave Medical, Inc.
Lithoplasty® M732LCC825D12021-01-14
Shockwave Medical, Inc.
Intravascular Lithotripsy (IVL) Generator and Connector Cable IVLGCCD2021-01-14
Shockwave Medical, Inc.
Intravascular Lithotripsy (IVL) Connector Cable IVLCC2021-01-14
SHOCKWAVE MEDICAL, INC.
Shockwave S4 IVL Catheter2020-02-06
SHOCKWAVE MEDICAL, INC.
Shockwave Medical, Inc. Peripheral Intravascular Lithotripsy (IVL) System2020-02-06
SHOCKWAVE MEDICAL, INC.
Shockwave S4 IVL Catheter2020-02-06
SHOCKWAVE MEDICAL, INC.
Shockwave Medical, Inc. Peripheral Lithoplasty System2020-02-06
SHOCKWAVE MEDICAL, INC.
Shockwave Medical, Inc. Peripheral Intravascular Lithotripsy (IVL) System2020-02-06
SHOCKWAVE MEDICAL, INC.
Shockwave M5 IVL Catheter2020-02-06
SHOCKWAVE MEDICAL, INC.
Lithoplasty Peripheral Balloon Dilatation Catheter2020-02-06
SHOCKWAVE MEDICAL, INC.
Shockwave S4 Intravascular Lithotripsy (IVL) Catheter2019-09-09
SHOCKWAVE MEDICAL, INC.
Shockwave Medical Peripheral Lithoplasty System2019-09-09
SHOCKWAVE MEDICAL, INC.
Shockwave Medical Intravascular Lithotripsy (IVL) Generator and Connector Cable2019-09-09
SHOCKWAVE MEDICAL, INC.
Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable2019-09-09
SHOCKWAVE MEDICAL, INC.
Shockwave M5 Intravascular Lithotripsy (IVL) Catheter2019-09-09
Shockwave Medical, Inc.
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator And Connector Cable Kit, IVL Connector Cable (Replacement)2019-08-07
SHOCKWAVE MEDICAL, INC.
Intravascular Lithotripsy (IVL) Generator and Connector Cable IVLGCC2019-06-18
SHOCKWAVE MEDICAL, INC.
Shockwave S4 Intravascular Lithotripsy (IVL) Catheter2019-03-20
SHOCKWAVE MEDICAL, INC.
Shockwave Medical Peripheral Lithoplasty System2019-03-20
SHOCKWAVE MEDICAL, INC.
Shockwave Medical Intravascular Lithotripsy (IVL) Generator and Connector Cable2019-03-20
SHOCKWAVE MEDICAL, INC.
Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable2019-03-20
SHOCKWAVE MEDICAL, INC.
Shockwave M5 Intravascular Lithotripsy (IVL) Catheter2019-03-20
SHOCKWAVE MEDICAL, INC.
Peripheral Intravascular Lithotripsy (IVL) System2019-03-20
SHOCKWAVE MEDICAL, INC.
Lithoplasty Peripheral Balloon Dilatation Catheter2019-03-20
SHOCKWAVE MEDICAL, INC.
Shockwave Medical TAVL System2019-03-20
SHOCKWAVE MEDICAL, INC.
Shockwave Medical Coronary Intravascular Lithotripsy System2019-03-20
SHOCKWAVE MEDICAL, INC.
Shockwave C2 Intravascular Lithotripsy (IVL) System2019-03-20
Shockwave Medical, Inc.
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, Lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable2018-07-26
Shockwave Medical, Inc.
Shockwave Medical Intravascular Lithotripsy (IVL) System2018-06-27
Shockwave Medical, Inc.
Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable2016-12-22
SHOCKWAVE MEDICAL, INC.
Shockwave S4 IVL Catheter2016-09-23
SHOCKWAVE MEDICAL, INC.
Shockwave Medical, Inc. Peripheral Lithoplasty System2016-09-23
SHOCKWAVE MEDICAL, INC.
Shockwave Medical, Inc. Peripheral Intravascular Lithotripsy (IVL) System2016-09-23
SHOCKWAVE MEDICAL, INC.
Shockwave M5 IVL Catheter2016-09-23
SHOCKWAVE MEDICAL, INC.
Lithoplasty Peripheral Balloon Dilatation Catheter2016-09-23
Shockwave Medical, Inc.
Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator And Connector Cable, Lithoplasty Connector Cable2016-09-14

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