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FDA 510(k)

EQUINOX Balloon Dilatation Catheter

K-Number: K190612 · 2019-12-06

ApplicantDornier Medtech America, Inc.
Decision Date2019-12-06
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EQUINOX Balloon Dilatation Catheter is a medical device manufactured by Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2019-12-06 under approval number K190612. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EQUINOX Balloon Dilatation Catheter?

EQUINOX Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2019-12-06. It is manufactured by Dornier Medtech America, Inc.. The 510(k) number is K190612.

When was EQUINOX Balloon Dilatation Catheter approved by the FDA?

EQUINOX Balloon Dilatation Catheter received FDA 510(k) clearance on 2019-12-06, under approval number K190612.

What company makes EQUINOX Balloon Dilatation Catheter?

EQUINOX Balloon Dilatation Catheter is manufactured by Dornier Medtech America, Inc..

What is the FDA product code for EQUINOX Balloon Dilatation Catheter?

The FDA product code for EQUINOX Balloon Dilatation Catheter is EZN.

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Related Devices (Code: EZN)

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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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