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FDA 510(k)

PROTEUS PTA Balloon Catheter with Embolic Capture Feature

K-Number: K172494 · 2017-12-15

ApplicantAngioslide, Ltd.
Decision Date2017-12-15
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROTEUS PTA Balloon Catheter with Embolic Capture Feature is the device name listed in this FDA 510(k) record. The listed applicant is Angioslide, Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K172494. 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 PROTEUS PTA Balloon Catheter with Embolic Capture Feature?

PROTEUS PTA Balloon Catheter with Embolic Capture Feature is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Angioslide, Ltd.. The 510(k) number is K172494.

When did PROTEUS PTA Balloon Catheter with Embolic Capture Feature receive FDA 510(k) clearance?

PROTEUS PTA Balloon Catheter with Embolic Capture Feature received FDA 510(k) clearance on 2017-12-15, under 510(k) number K172494.

Who is the listed applicant for PROTEUS PTA Balloon Catheter with Embolic Capture Feature?

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

What is the FDA product code for PROTEUS PTA Balloon Catheter with Embolic Capture Feature?

The FDA product code for PROTEUS PTA Balloon Catheter with Embolic Capture Feature 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.

NCT07247864Balloon Guide Catheter Combined With Filter Protection for Carotid Artery StentingRECRUITINGNCT05734157CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal ArteryCOMPLETEDNCT06330493AcoArt Litos PCB Below-the-knee Global TrialTERMINATEDNCT06687590Serranator POINT FORCE RegistryRECRUITINGNCT07576790Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)NOT_YET_RECRUITINGNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

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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