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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 a medical device manufactured by Angioslide, Ltd.. It received FDA 510(k) clearance on 2017-12-15 under approval 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. It is manufactured by Angioslide, Ltd.. The 510(k) number is K172494.

When was PROTEUS PTA Balloon Catheter with Embolic Capture Feature approved by the FDA?

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

What company makes PROTEUS PTA Balloon Catheter with Embolic Capture Feature?

PROTEUS PTA Balloon Catheter with Embolic Capture Feature is manufactured by Angioslide, Ltd..

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

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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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