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FDA 510(k)

Polux , Minerva and Atropos PTA Balloon Dilatation Catheter

K-Number: K160256 · 2016-07-29

Decision Date2016-07-29
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Polux , Minerva and Atropos PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K160256. 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 Polux , Minerva and Atropos PTA Balloon Dilatation Catheter?

Polux , Minerva and Atropos PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Brosmed Medical Co., Ltd.. The 510(k) number is K160256.

When did Polux , Minerva and Atropos PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

Polux , Minerva and Atropos PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2016-07-29, under 510(k) number K160256.

Who is the listed applicant for Polux , Minerva and Atropos PTA Balloon Dilatation Catheter?

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

What is the FDA product code for Polux , Minerva and Atropos PTA Balloon Dilatation Catheter?

The FDA product code for Polux , Minerva and Atropos PTA Balloon Dilatation 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.

Other records listing Brosmed Medical Co., 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.

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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.

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.