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.

USA

NASDAQ

SWAV

DUNS 055514478

FDA Registration(s)

• Registration Number: 3015053858
• FEI Number: 3015053858
• Name: SHOCKWAVE MEDICAL, INC.
• Owner & Operator: Shockwave Medical, Inc.
• Contact Address: 5403 Betsy Ross Drive ; Santa Clara CA 95054 US
• Official Correspondent:
  • Peter Nowakowski
  • 001-408-5502609-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5403 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	Device	Date
GUDID 00195451000621 Shockwave Medical, Inc.	Shockwave C2 Aero Coronary IVL Catheter C2AIVL4012	2025-07-18
GUDID 00195451000614 Shockwave Medical, Inc.	Shockwave C2 Aero Coronary IVL Catheter C2AIVL3512	2025-07-18
GUDID 00195451000607 Shockwave Medical, Inc.	Shockwave C2 Aero Coronary IVL Catheter C2AIVL3012	2025-07-18
GUDID 00195451000591 Shockwave Medical, Inc.	Shockwave C2 Aero Coronary IVL Catheter C2AIVL2512	2025-07-18
GUDID 00195451000836 Shockwave Medical, Inc.	Shockwave CS Guide Catheter SWCSGC01	2025-06-10
GUDID 00195451000799 Shockwave Medical, Inc.	Javelin Peripheral IVL Catheter JVNPIVLF	2024-10-17
GUDID 00195451000584 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripher E8IVL060080	2024-04-25
GUDID 00195451000577 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera E8IVL050080	2024-04-25
GUDID 00195451000560 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera E8IVL040080	2024-04-25
GUDID 00195451000553 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera E8IVL035080	2024-04-25
GUDID 00195451000546 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera E8IVL030080	2024-04-25
GUDID 00195451000539 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera E8IVL025080	2024-04-25
GUDID 00195451000034 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary C2PIVL4012	2023-08-24
GUDID 00195451000027 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary C2PIVL3512	2023-08-24
GUDID 00195451000010 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary C2PIVL3012	2023-08-24
GUDID 00195451000003 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary C2PIVL2512	2023-08-24
GUDID 00195451000355 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable IVLGCCDX	2023-04-05
GUDID 00195451000461 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable IVLGCCDC	2022-12-13
GUDID 00195451000416 Shockwave Medical, Inc.	Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter L6IVL120030	2022-11-01
GUDID 00195451000409 Shockwave Medical, Inc.	Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter L6IVL100030	2022-11-01
GUDID 00195451000393 Shockwave Medical, Inc.	Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter L6IVL090030	2022-11-01
GUDID 00195451000386 Shockwave Medical, Inc.	Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter L6IVL080030	2022-11-01
PMN K221852 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System With The Shockwave L6 Peripheral IVL Catheter	2022-08-16
PMA P200039S004 Shockwave Medical, Inc.	Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)	2022-01-04
PMA P200039S003 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter	2021-07-22
GUDID 00195451000348 Shockwave Medical, Inc.	Shockwave S4 S4IVLK4040	2021-06-16
GUDID 00195451000331 Shockwave Medical, Inc.	Shockwave S4 S4IVLK3540	2021-06-16
GUDID 00195451000324 Shockwave Medical, Inc.	Shockwave S4 S4IVLK3040	2021-06-16
GUDID 00195451000317 Shockwave Medical, Inc.	Shockwave S4 S4IVLK2540	2021-06-16
PMA P200039S002 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter	2021-06-04
GUDID 00195451000287 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ M5PIVL8060	2021-05-19
GUDID 00195451000270 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ M5PIVL7060	2021-05-19
GUDID 00195451000263 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ M5PIVL6560	2021-05-19
GUDID 00195451000256 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ M5PIVL6060	2021-05-19
GUDID 00195451000249 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ M5PIVL5560	2021-05-19
GUDID 00195451000232 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ M5PIVL5060	2021-05-19
GUDID 00195451000225 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ M5PIVL4560	2021-05-19
GUDID 00195451000218 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ M5PIVL4060	2021-05-19
GUDID 00195451000201 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ M5PIVL3560	2021-05-19
PMN K203365 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System With The Shockwave M5+ Peripheral IVL Catheter	2021-04-22
PMA P200039S001 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter	2021-04-09
GUDID 00195451000119 Shockwave Medical, Inc.	Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL4012	2021-02-25
GUDID 00195451000102 Shockwave Medical, Inc.	Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL3512	2021-02-25
GUDID 00195451000096 Shockwave Medical, Inc.	Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL3012	2021-02-25
GUDID 00195451000089 Shockwave Medical, Inc.	Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL2512	2021-02-25
GUDID 00195451000300 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) Connector Cable IVLCC	2021-02-19
GUDID 00195451000294 Shockwave Medical, Inc.	Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable IVLGCCD	2021-02-19
PMA P200039 Shockwave Medical, Inc.	Shockwave Intravascular Litbotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter	2021-02-12
GUDID 00195451000195 Shockwave Medical, Inc.	Shockwave M5 M5IVL7060	2021-02-12
GUDID 00195451000188 Shockwave Medical, Inc.	Shockwave M5 M5IVL6560	2021-02-12
GUDID 00195451000171 Shockwave Medical, Inc.	Shockwave M5 M5IVL6060	2021-02-12
GUDID 00195451000164 Shockwave Medical, Inc.	Shockwave M5 M5IVL5560	2021-02-12
GUDID 00195451000157 Shockwave Medical, Inc.	Shockwave M5 M5IVL5060	2021-02-12
GUDID 00195451000140 Shockwave Medical, Inc.	Shockwave M5 M5IVL4560	2021-02-12
GUDID 00195451000133 Shockwave Medical, Inc.	Shockwave M5 M5IVL4060	2021-02-12
GUDID 00195451000126 Shockwave Medical, Inc.	Shockwave M5 M5IVL3560	2021-02-12
GUDID 00195451000072 Shockwave Medical, Inc.	Shockwave S4 S4IVL4040	2021-02-12
GUDID 00195451000065 Shockwave Medical, Inc.	Shockwave S4 S4IVL3540	2021-02-12
GUDID 00195451000058 Shockwave Medical, Inc.	Shockwave S4 S4IVL3040	2021-02-12
GUDID 00195451000041 Shockwave Medical, Inc.	Shockwave S4 S4IVL2540	2021-02-12
GUDID M732S4IVL40400 Shockwave Medical, Inc.	Shockwave S4 S4IVL4040	2021-01-14
GUDID M732S4IVL35400 Shockwave Medical, Inc.	Shockwave S4 S4IVL3540	2021-01-14
GUDID M732S4IVL30400 Shockwave Medical, Inc.	Shockwave S4 S4IVL3040	2021-01-14
GUDID M732S4IVL25400 Shockwave Medical, Inc.	Shockwave S4 S4IVL2540	2021-01-14
GUDID M732M5IVL70600 Shockwave Medical, Inc.	Shockwave M5 M5IVL7060	2021-01-14
GUDID M732M5IVL65600 Shockwave Medical, Inc.	Shockwave M5 M5IVL6560	2021-01-14
GUDID M732M5IVL60600 Shockwave Medical, Inc.	Shockwave M5 M5IVL6060	2021-01-14
GUDID M732M5IVL55600 Shockwave Medical, Inc.	Shockwave M5 M5IVL5560	2021-01-14
GUDID M732M5IVL50600 Shockwave Medical, Inc.	Shockwave M5 M5IVL5060	2021-01-14
GUDID M732M5IVL45600 Shockwave Medical, Inc.	Shockwave M5 M5IVL4560	2021-01-14
GUDID M732M5IVL40600 Shockwave Medical, Inc.	Shockwave M5 M5IVL4060	2021-01-14
GUDID M732M5IVL35600 Shockwave Medical, Inc.	Shockwave M5 M5IVL3560	2021-01-14
GUDID M732LPBC7060DX1 Shockwave Medical, Inc.	Lithoplasty® M732LPBC7060DX1	2021-01-14
GUDID M732LPBC6560DX1 Shockwave Medical, Inc.	Lithoplasty® M732LPBC6560DX1	2021-01-14
GUDID M732LPBC6060DX1 Shockwave Medical, Inc.	Lithoplasty® M732LPBC6060DX1	2021-01-14
GUDID M732LPBC5560DX1 Shockwave Medical, Inc.	Lithoplasty® M732LPBC5560DX1	2021-01-14
GUDID M732LPBC5060DX1 Shockwave Medical, Inc.	Lithoplasty® M732LPBC5060DX1	2021-01-14
GUDID M732LPBC4560DX1 Shockwave Medical, Inc.	Lithoplasty® M732LPBC4560DX1	2021-01-14
GUDID M732LPBC4060DX1 Shockwave Medical, Inc.	Lithoplasty® M732LPBC4060DX1	2021-01-14
GUDID M732LPBC3560DX1 Shockwave Medical, Inc.	Lithoplasty® M732LPBC3560DX1	2021-01-14
GUDID M732LG825D1 Shockwave Medical, Inc.	Lithoplasty® M732LGCC825DX1	2021-01-14
GUDID M732LCC825D1 Shockwave Medical, Inc.	Lithoplasty® M732LCC825D1	2021-01-14
GUDID M732IVLGCCD0 Shockwave Medical, Inc.	Intravascular Lithotripsy (IVL) Generator and Connector Cable IVLGCCD	2021-01-14
GUDID M732IVLCC0 Shockwave Medical, Inc.	Intravascular Lithotripsy (IVL) Connector Cable IVLCC	2021-01-14
PMN K180454 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave S4 IVL Catheter	2020-02-06
PMN K180454 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave Medical, Inc. Peripheral Intravascular Lithotripsy (IVL) System	2020-02-06
PMN K163306 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave S4 IVL Catheter	2020-02-06
PMN K163306 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave Medical, Inc. Peripheral Lithoplasty System	2020-02-06
PMN K163306 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave Medical, Inc. Peripheral Intravascular Lithotripsy (IVL) System	2020-02-06
PMN K163306 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave M5 IVL Catheter	2020-02-06
PMN K163306 | PPN SHOCKWAVE MEDICAL, INC.	Lithoplasty Peripheral Balloon Dilatation Catheter	2020-02-06
PMN K191840 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave S4 Intravascular Lithotripsy (IVL) Catheter	2019-09-09
PMN K191840 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave Medical Peripheral Lithoplasty System	2019-09-09
PMN K191840 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave Medical Intravascular Lithotripsy (IVL) Generator and Connector Cable	2019-09-09
PMN K191840 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable	2019-09-09
PMN K191840 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave M5 Intravascular Lithotripsy (IVL) Catheter	2019-09-09
PMN K191840 Shockwave Medical, Inc.	Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator And Connector Cable Kit, IVL Connector Cable (Replacement)	2019-08-07
GUDID M732IVLGCC0 SHOCKWAVE MEDICAL, INC.	Intravascular Lithotripsy (IVL) Generator and Connector Cable IVLGCC	2019-06-18
PMN K180958 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave S4 Intravascular Lithotripsy (IVL) Catheter	2019-03-20
PMN K180958 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave Medical Peripheral Lithoplasty System	2019-03-20
PMN K180958 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave Medical Intravascular Lithotripsy (IVL) Generator and Connector Cable	2019-03-20
PMN K180958 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable	2019-03-20
PMN K180958 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave M5 Intravascular Lithotripsy (IVL) Catheter	2019-03-20
PMN K180958 | PPN SHOCKWAVE MEDICAL, INC.	Peripheral Intravascular Lithotripsy (IVL) System	2019-03-20
PMN K180958 | PPN SHOCKWAVE MEDICAL, INC.	Lithoplasty Peripheral Balloon Dilatation Catheter	2019-03-20
OZT SHOCKWAVE MEDICAL, INC.	Shockwave Medical TAVL System	2019-03-20
MCX SHOCKWAVE MEDICAL, INC.	Shockwave Medical Coronary Intravascular Lithotripsy System	2019-03-20
MCX SHOCKWAVE MEDICAL, INC.	Shockwave C2 Intravascular Lithotripsy (IVL) System	2019-03-20
PMN K180958 Shockwave Medical, Inc.	Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, Lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable	2018-07-26
PMN K180454 Shockwave Medical, Inc.	Shockwave Medical Intravascular Lithotripsy (IVL) System	2018-06-27
PMN K163306 Shockwave Medical, Inc.	Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable	2016-12-22
PMN K161384 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave S4 IVL Catheter	2016-09-23
PMN K161384 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave Medical, Inc. Peripheral Lithoplasty System	2016-09-23
PMN K161384 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave Medical, Inc. Peripheral Intravascular Lithotripsy (IVL) System	2016-09-23
PMN K161384 | PPN SHOCKWAVE MEDICAL, INC.	Shockwave M5 IVL Catheter	2016-09-23
PMN K161384 | PPN SHOCKWAVE MEDICAL, INC.	Lithoplasty Peripheral Balloon Dilatation Catheter	2016-09-23
PMN K161384 Shockwave Medical, Inc.	Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator And Connector Cable, Lithoplasty Connector Cable	2016-09-14

Similar & Related FDA Registered Companies

• Shockwave Medical, Inc.5403 Betsy Ross Drivesanta Clara, CA 95054 PMA NumberP200039 Supplement NumberS009 Date Received12/08/2022 Decision Date02/02/2023 Product Code QMG  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• Shockwave Medical, Inc.5403 Betsy Ross Drivesanta Clara, CA 95054 PMA NumberP200039 Supplement NumberS008 Date Received10/11/2022 Decision Date12/13/2022 Product Code QMG  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Shockwave Medical, Inc.5403 Betsy Ross Drivesanta Clara, CA 95054 PMA NumberP200039 Supplement NumberS007 Date Received06/03/2022 Decision Date09/01/2022 Product Code QMG  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Shockwave Medical, Inc.5403 Betsy Ross Drivesanta Clara, CA 95054 PMA NumberP200039 Supplement NumberS006 Date Received12/22/2021 Decision Date03/23/2022 Product Code QMG  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	81RT5	SHOCKWAVE MEDICAL, INC.
CAGE Code	81RT5	SHOCKWAVE MEDICAL, INC.
S.A.M. Registration	81RT5 [55514478]	SHOCKWAVE MEDICAL, INC.
SEC	0001642545	ShockWave Medical, Inc. of DELAWARE