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FDA 510(k)

Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable

K-Number: K180958 · 2018-07-26

ApplicantShockwave Medical, Inc.
Decision Date2018-07-26
Product CodePPN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable is a medical device manufactured by Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2018-07-26 under approval number K180958. 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 M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable?

Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable is a medical device that received FDA 510(k) clearance on 2018-07-26. It is manufactured by Shockwave Medical, Inc.. The 510(k) number is K180958.

When was Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable approved by the FDA?

Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable received FDA 510(k) clearance on 2018-07-26, under approval number K180958.

What company makes Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable?

Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable is manufactured by Shockwave Medical, Inc..

What is the FDA product code for Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable?

The FDA product code for Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable is PPN.

Related Clinical Trials

NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT06662500 FORWARD CAD IDE Study RECRUITING NCT07510438 AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease RECRUITING NCT07587255 Efficacy of Extracorporeal Shockwave Therapy on Plantar Fasciitis in Patients With Peripheral Neuropathy NOT_YET_RECRUITING NCT06149650 Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study RECRUITING NCT07579611 Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy NOT_YET_RECRUITING

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 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 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. K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave 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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