FDA 510(k) Applications for Medical Device Product Code "PPN"

FDA 510(k) Number Applicant Device Name Decision Date
K161384 Shockwave Medical, Inc. Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable 09/14/2016
K163306 Shockwave Medical, Inc. Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable 12/22/2016
K180958 Shockwave Medical, Inc. Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable 07/26/2018
K180454 Shockwave Medical, Inc. Shockwave Medical Intravascular Lithotripsy (IVL) System 06/27/2018


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