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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 the device name listed in this FDA 510(k) record. The listed applicant is Straub Medical AG. It received FDA 510(k) clearance on 2018-04-12 under 510(k) 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. The listed applicant is Straub Medical AG. The 510(k) number is K172315.

When did Straub Endovascular System receive FDA 510(k) clearance?

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

Who is the listed applicant for Straub Endovascular System?

The FDA 510(k) record lists Straub Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Straub Endovascular System?

The FDA product code for Straub Endovascular System is MCW.

Related Devices (Code: MCW)

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.

K260244Auryon Atherectomy SystemEximo MedicalK250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectraneticsK242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

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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