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FDA 510(k)

Finesse™ Injectable PTA Balloon Dilatation Catheter

K-Number: K230263 · 2023-05-26

ApplicantSumma Therapeutics, LLC
Decision Date2023-05-26
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Finesse™ Injectable PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Summa Therapeutics, LLC. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230263. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Finesse™ Injectable PTA Balloon Dilatation Catheter?

Finesse™ Injectable PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Summa Therapeutics, LLC. The 510(k) number is K230263.

When did Finesse™ Injectable PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

Finesse™ Injectable PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230263.

Who is the listed applicant for Finesse™ Injectable PTA Balloon Dilatation Catheter?

The FDA 510(k) record lists Summa Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Finesse™ Injectable PTA Balloon Dilatation Catheter?

The FDA product code for Finesse™ Injectable PTA Balloon Dilatation Catheter is LIT.

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.

NCT05509296Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery DiseaseCOMPLETEDNCT05734157CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal ArteryCOMPLETEDNCT06330493AcoArt Litos PCB Below-the-knee Global TrialTERMINATEDNCT06687590Serranator POINT FORCE RegistryRECRUITINGNCT06832631VITUS Post-Market RegistryACTIVE_NOT_RECRUITINGNCT07397390an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified LesionsENROLLING_BY_INVITATION

Other records listing Summa Therapeutics, LLC 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.

K241740Finesse Injectable™ PTA Balloon Dilatation Catheter

Related Devices (Code: LIT)

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.

K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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