FDA 510(k)

Shockwave Medical Intravascular Lithotripsy (IVL) System

Numéro K : K180454 · 2018-06-27

Date de décision2018-06-27

Code produitPPN

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Shockwave Medical Intravascular Lithotripsy (IVL) System is the device name listed in this FDA 510(k) record. The listed applicant is Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2018-06-27 under 510(k) number K180454. The device is classified under product code PPN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K180454.

When did Shockwave Medical Intravascular Lithotripsy (IVL) System receive FDA 510(k) clearance?

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

Who is the listed applicant for Shockwave Medical Intravascular Lithotripsy (IVL) System?

The FDA 510(k) record lists Shockwave Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Autres dossiers indiquant Shockwave Medical, Inc. en tant que demandeur

K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter K243757Shockwave CS Guide Catheter K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter

Voir tous les 13 dispositifs →

Dispositifs connexes (Code : PPN)

K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) CatheterShockwave Medical, Inc.K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterShockwave Medical, Inc.K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.

Source officielle

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