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510(k) Data Aggregation

K Number

Device Name

EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026

Manufacturer

MICRO THERAPEUTICS, INC.

Date Cleared

2001-05-18

(121 days)

Product Code

Regulation Number

Type

Panel

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N/A

Why did this record match?

Device Name :

EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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