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FDA 510(k)

Straub Endovascular System

K-Number: K172315 · 2018-04-12

ApplicantStraub Medical AG
Decision Date2018-04-12
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Straub Endovascular System is a medical device manufactured by Straub Medical AG. It received FDA 510(k) clearance on 2018-04-12 under approval number K172315. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straub Endovascular System?

Straub Endovascular System is a medical device that received FDA 510(k) clearance on 2018-04-12. It is manufactured by Straub Medical AG. The 510(k) number is K172315.

When was Straub Endovascular System approved by the FDA?

Straub Endovascular System received FDA 510(k) clearance on 2018-04-12, under approval number K172315.

What company makes Straub Endovascular System?

Straub Endovascular System is manufactured by Straub Medical AG.

What is the FDA product code for Straub Endovascular System?

The FDA product code for Straub Endovascular System is MCW.

Related Clinical Trials

NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure RECRUITING NCT06710938 Thoracoabdominal Artery Stent Graft System Exploratory Study RECRUITING NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT04503395 ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES RECRUITING NCT03298477 EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study COMPLETED NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING

Related PubMed Literature

PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024) PMID: 29988408 Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke. Frontiers in neurology (2018)

Related Devices (Code: MCW)

K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledAvinger, Inc. K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. K160827Pantheris CatheterAvinger, Inc. K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, 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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