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Equinox Occulsion Balloon System (# 104-4015 +4 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K010162

by Micro Therapeutics, Inc.

Identifiers

510(k) Number
K010162 FDA 510(k)
FDA Product Code
MJN FDA 510(k)
Models / Variants
# 104-4015 FDA 510(k)
104-4018 FDA 510(k)
104-4021 FDA 510(k)
104-4023 FDA 510(k)
104-4026 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4450 FDA 510(k)
Regulation Number
870.4450 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Equinox Occulsion Balloon System (# 104-4015 +4 more) by Micro Therapeutics, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 5 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Micro Therapeutics, Inc.

Sources (1)

  • FDA 510(k) K010162 24 fields · synced Jun 18, 2026