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FDA 510(k)

Shockwave CS Guide Catheter

K-Number: K243757 · 2025-05-02

ApplicantShockwave Medical, Inc.
Decision Date2025-05-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Shockwave CS Guide Catheter is a medical device manufactured by Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2025-05-02 under approval number K243757. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shockwave CS Guide Catheter?

Shockwave CS Guide Catheter is a medical device that received FDA 510(k) clearance on 2025-05-02. It is manufactured by Shockwave Medical, Inc.. The 510(k) number is K243757.

When was Shockwave CS Guide Catheter approved by the FDA?

Shockwave CS Guide Catheter received FDA 510(k) clearance on 2025-05-02, under approval number K243757.

What company makes Shockwave CS Guide Catheter?

Shockwave CS Guide Catheter is manufactured by Shockwave Medical, Inc..

What is the FDA product code for Shockwave CS Guide Catheter?

The FDA product code for Shockwave CS Guide Catheter is DQY.

Related Clinical Trials

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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 K180454Shockwave Medical Intravascular Lithotripsy (IVL) System 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

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Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire 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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