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FDA 510(k)

Serranator Alto PTA Serration Balloon Catheter

K-Number: K163380 · 2017-02-13

ApplicantCagent Vascular, LLC
Decision Date2017-02-13
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Serranator Alto PTA Serration Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cagent Vascular, LLC. It received FDA 510(k) clearance on 2017-02-13 under 510(k) number K163380. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Serranator Alto PTA Serration Balloon Catheter?

Serranator Alto PTA Serration Balloon Catheter is a medical device that received FDA 510(k) clearance on 2017-02-13. The listed applicant is Cagent Vascular, LLC. The 510(k) number is K163380.

When did Serranator Alto PTA Serration Balloon Catheter receive FDA 510(k) clearance?

Serranator Alto PTA Serration Balloon Catheter received FDA 510(k) clearance on 2017-02-13, under 510(k) number K163380.

Who is the listed applicant for Serranator Alto PTA Serration Balloon Catheter?

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

What is the FDA product code for Serranator Alto PTA Serration Balloon Catheter?

The FDA product code for Serranator Alto PTA Serration Balloon Catheter is PNO.

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.

NCT06687590Serranator POINT FORCE RegistryRECRUITINGNCT05734157CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal ArteryCOMPLETEDNCT06330493AcoArt Litos PCB Below-the-knee Global TrialRECRUITING

Other records listing Cagent Vascular, 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.

K220704Serranator PTA Serration Balloon CatheterK213728Serranator PTA Serration Balloon CatheterK203437Serranator PTA Serration Balloon CatheterK193181Serranator PTA Serration Balloon Catheter

Related Devices (Code: PNO)

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.

K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLCK232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)Goodman Co., 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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