EQUINOX OCCLUSION BALLOON SYSTEM— 510(k) K990487

Name: FDA 510(k) clearance K990487
Creator: U.S. Food and Drug Administration
Published: 1999-08-31

Unknown

Micro Therapeutics, Inc.

FDA 510(k) clearance K990487 for EQUINOX OCCLUSION BALLOON SYSTEM, Unknown on 1999-08-31. Applicant: Micro Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Micro Therapeutics, Inc.
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 1999-02-16
Decision date: 1999-08-31
Decision: Unknown
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MJN

view all

K243795 — pREBOA-PRO Catheter2025-09-05
K251358 — Bridge Plus Occlusion Balloon (590-002)2025-06-24
K221294 — preCARDIA Occlusion System2023-06-30
K214060 — LANDMARK REBOA Catheter2022-09-19
K211610 — Fogarty Occlusion Catheter2022-02-14

More clearances from Micro Therapeutics, Inc.

view all

K113289 — ORION MICRO CATHETER2012-08-01
K113454 — 14 WIRE STANDARD, 14 WIRE LS2012-02-24
K090870 — ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY2009-05-01
K090046 — CONCERTO DETACHABLE COIL SYSTEM2009-02-27
K081465 — AXIUM DETACHABLE COIL SYSTEM2008-08-19

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.