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FDA 510(k)

Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable

K-Number: K163306 · 2016-12-22

ApplicantShockwave Medical, Inc.
Decision Date2016-12-22
Product CodePPN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable 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 2016-12-22 under 510(k) number K163306. 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 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable?

Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K163306.

When did Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable receive FDA 510(k) clearance?

Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable received FDA 510(k) clearance on 2016-12-22, under 510(k) number K163306.

Who is the listed applicant for Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable?

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 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable?

The FDA product code for Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable is PPN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05858905FORWARD PAD IDE Study With the Shockwave Javelin IVL CatheterCOMPLETEDNCT02276547Early Feasibility Study of the Neovasc Tiara™ Mitral Valve SystemCOMPLETEDNCT02710435REDUCER-I: An Observational Study of the Neovasc Reducer™ SystemACTIVE_NOT_RECRUITINGNCT05058456Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL SystemCOMPLETEDNCT05102019Efficacy of the COronary SInus Reducer in Patients With Refractory Angina IIRECRUITINGNCT05755711Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery DiseaseACTIVE_NOT_RECRUITING

Other records listing Shockwave Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterPMA P200039Shockwave intravascular lithotripsy systemK243757Shockwave CS Guide CatheterK242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) CatheterK240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL CatheterK240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter

View all 14 devices →

Related Devices (Code: PPN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.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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