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FDA 510(k)

EQUINOX OCCLUSION BALLOON SYSTEM

K-Number: K990487 · 1999-08-31

ApplicantMicro Therapeutics, Inc.
Decision Date1999-08-31
Product CodeMJN
Advisory CommitteeCV
DecisionUnknown

Device Summary

EQUINOX OCCLUSION BALLOON SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc.. It received FDA 510(k) clearance on 1999-08-31 under 510(k) number K990487. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the EQUINOX OCCLUSION BALLOON SYSTEM?

EQUINOX OCCLUSION BALLOON SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-31. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K990487.

When did EQUINOX OCCLUSION BALLOON SYSTEM receive FDA 510(k) clearance?

EQUINOX OCCLUSION BALLOON SYSTEM received FDA 510(k) clearance on 1999-08-31, under 510(k) number K990487.

Who is the listed applicant for EQUINOX OCCLUSION BALLOON SYSTEM?

The FDA 510(k) record lists Micro Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EQUINOX OCCLUSION BALLOON SYSTEM?

The FDA product code for EQUINOX OCCLUSION BALLOON SYSTEM is MJN.

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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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