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FDA 510(k)

Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)

K-Number: K191840 · 2019-08-07

ApplicantShockwave Medical, Inc.
Decision Date2019-08-07
Product CodePPN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) 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 2019-08-07 under 510(k) number K191840. 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 Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)?

Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) is a medical device that received FDA 510(k) clearance on 2019-08-07. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K191840.

When did Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) receive FDA 510(k) clearance?

Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) received FDA 510(k) clearance on 2019-08-07, under 510(k) number K191840.

Who is the listed applicant for Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)?

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 Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)?

The FDA product code for Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) 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.

NCT05058456Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL SystemCOMPLETEDNCT05858905FORWARD PAD IDE Study With the Shockwave Javelin IVL CatheterCOMPLETEDNCT06662500FORWARD CAD IDE StudyRECRUITINGNCT07062471Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study)RECRUITINGNCT07512128Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)NOT_YET_RECRUITINGNCT05007925Disrupt PAD BTK II Study With the Shockwave Peripheral IVL SystemCOMPLETED

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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