Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
K-Number: K221041 · 2022-04-25
ApplicantShockwave Medical, Inc.
Decision Date2022-04-25
Product CodePPN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is a medical device manufactured by Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2022-04-25 under approval number K221041. 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 Peripheral Intravascular Lithotripsy (IVL) System?
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is a medical device that received FDA 510(k) clearance on 2022-04-25. It is manufactured by Shockwave Medical, Inc.. The 510(k) number is K221041.
When was Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System approved by the FDA?
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System received FDA 510(k) clearance on 2022-04-25, under approval number K221041.
What company makes Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System?
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is manufactured by Shockwave Medical, Inc..
What is the FDA product code for Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System?
The FDA product code for Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is PPN.
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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
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.
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.
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.