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FDA 510(k)

Chameleon PTA Balloon Catheter

K-Number: K170635 · 2017-03-30

ApplicantAv Medical Technologies, Ltd.
Decision Date2017-03-30
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Chameleon PTA Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Av Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2017-03-30 under 510(k) number K170635. 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 Chameleon PTA Balloon Catheter?

Chameleon PTA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2017-03-30. The listed applicant is Av Medical Technologies, Ltd.. The 510(k) number is K170635.

When did Chameleon PTA Balloon Catheter receive FDA 510(k) clearance?

Chameleon PTA Balloon Catheter received FDA 510(k) clearance on 2017-03-30, under 510(k) number K170635.

Who is the listed applicant for Chameleon PTA Balloon Catheter?

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

What is the FDA product code for Chameleon PTA Balloon Catheter?

The FDA product code for Chameleon PTA Balloon 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.

NCT05734157CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal ArteryCOMPLETEDNCT06330493AcoArt Litos PCB Below-the-knee Global TrialTERMINATEDNCT06687590Serranator POINT FORCE RegistryRECRUITING

Other records listing Av Medical Technologies, Ltd. 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.

K163231Chameleon PTA Balloon 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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