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FDA 510(k)

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter

K-Number: K262201 · 2026-07-27

ApplicantShockwave Medical, Inc.
Decision Date2026-07-27
Product CodePPN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2026-07-27 under 510(k) number K262201. The device is classified under product code PPN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter?

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter is a medical device that received FDA 510(k) clearance on 2026-07-27. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K262201.

When did Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter receive FDA 510(k) clearance?

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter received FDA 510(k) clearance on 2026-07-27, under 510(k) number K262201.

Who is the listed applicant for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter?

The FDA 510(k) record lists Shockwave Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter?

The FDA product code for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter is PPN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05858905FORWARD PAD IDE Study With the Shockwave Javelin IVL CatheterCOMPLETEDNCT05058456Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL SystemCOMPLETEDNCT06662500FORWARD CAD IDE StudyRECRUITINGNCT07062471Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study)RECRUITINGNCT07512128Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)NOT_YET_RECRUITINGNCT05007925Disrupt PAD BTK II Study With the Shockwave Peripheral IVL SystemCOMPLETED

Other records listing Shockwave Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P200039Shockwave intravascular lithotripsy systemK243757Shockwave CS Guide CatheterK242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) CatheterK240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterK240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterK221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter

View all 14 devices →

Related Devices (Code: PPN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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