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FDA PMA

Shockwave intravascular lithotripsy system

PMA Number: P200039 · 2026-09-11

ApplicantShockwave Medical, Inc.
Decision Date2026-09-11
PMA NumberP200039
Product CodeQMG
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Shockwave intravascular lithotripsy system 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 2026-09-11. The device is classified under product code QMG. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Shockwave intravascular lithotripsy system?

Shockwave intravascular lithotripsy system is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Shockwave Medical, Inc..

When did Shockwave intravascular lithotripsy system receive FDA 510(k) clearance?

The clearance date for Shockwave intravascular lithotripsy system can be found in the official FDA records.

Who is the listed applicant for Shockwave intravascular lithotripsy system?

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 system?

The FDA product code for Shockwave intravascular lithotripsy system is QMG.

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.

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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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