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FDA 510(k)

MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM

K-Number: K021066 · 2002-06-18

ApplicantMicro Therapeutics, Inc.
Decision Date2002-06-18
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HYPERGLIDE 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 2002-06-18 under 510(k) number K021066. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM?

MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM is a medical device that received FDA 510(k) clearance on 2002-06-18. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K021066.

When did MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM received FDA 510(k) clearance on 2002-06-18, under 510(k) number K021066.

Who is the listed applicant for MODIFICATION TO HYPERGLIDE 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 MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM?

The FDA product code for MODIFICATION TO HYPERGLIDE 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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