Equinox Occlusion Balloon System

FDA 510(k) K990487 · Micro Therapeutics, Inc.

Unknown

510(k) numberK990487

Submission

Device name
Equinox Occlusion Balloon System
Applicant
Micro Therapeutics, Inc.
Irvine, CA, US
Received
February 16, 1999
Decision date
August 31, 1999
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MJN – Catheter, Intravascular Occluding, Temporary
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4450
Specialty
Cardiovascular

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Questions and answers

When was Equinox Occlusion Balloon System cleared by the FDA?

Equinox Occlusion Balloon System (K990487) received a 510(k) decision of Unknown on August 31, 1999, 196 days after the submission was received.

What is the product code of K990487?

The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.