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FDA 510(k)

Shockwave Medical Intravascular Lithotripsy (IVL) System

K-Number: K180454 · 2018-06-27

ApplicantShockwave Medical, Inc.
Decision Date2018-06-27
Product CodePPN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Shockwave Medical Intravascular Lithotripsy (IVL) System is a medical device manufactured by Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2018-06-27 under approval number K180454. 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 Medical Intravascular Lithotripsy (IVL) System?

Shockwave Medical Intravascular Lithotripsy (IVL) System is a medical device that received FDA 510(k) clearance on 2018-06-27. It is manufactured by Shockwave Medical, Inc.. The 510(k) number is K180454.

When was Shockwave Medical Intravascular Lithotripsy (IVL) System approved by the FDA?

Shockwave Medical Intravascular Lithotripsy (IVL) System received FDA 510(k) clearance on 2018-06-27, under approval number K180454.

What company makes Shockwave Medical Intravascular Lithotripsy (IVL) System?

Shockwave Medical Intravascular Lithotripsy (IVL) System is manufactured by Shockwave Medical, Inc..

What is the FDA product code for Shockwave Medical Intravascular Lithotripsy (IVL) System?

The FDA product code for Shockwave Medical Intravascular Lithotripsy (IVL) System is PPN.

Related Clinical Trials

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Shockwave Medical, Inc.

K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter

View all 13 devices →

Related Devices (Code: PPN)

K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector CableShockwave Medical, Inc. K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector CableShockwave Medical, Inc. K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector CableShockwave Medical, Inc. K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)Shockwave Medical, Inc. K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL CatheterShockwave Medical, Inc. K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave 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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