SAPPHIRE DETACHABLE FIBER COILS— 510(k) K031852

Name: FDA 510(k) clearance K031852
Creator: U.S. Food and Drug Administration
Published: 2003-08-20

Substantially Equivalent

Micro Therapeutics, Inc.

FDA 510(k) clearance K031852 for SAPPHIRE DETACHABLE FIBER COILS, Substantially Equivalent on 2003-08-20. Applicant: Micro Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Micro Therapeutics, Inc.
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2003-06-16
Decision date: 2003-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Micro Therapeutics, Inc.

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K113289 — ORION MICRO CATHETER2012-08-01
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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 HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.