MICRUS MICROCOIL DELIVERY SYSTEM, MDS03— 510(k) K002056

Name: FDA 510(k) clearance K002056
Creator: U.S. Food and Drug Administration
Published: 2001-01-11

Substantially Equivalent

Micrus Corp.

FDA 510(k) clearance K002056 for MICRUS MICROCOIL DELIVERY SYSTEM, MDS03, Substantially Equivalent on 2001-01-11. Applicant: Micrus Corp.. Device class: 2.

Clearance details

Applicant: Micrus Corp.
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2000-07-06
Decision date: 2001-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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K031578 — MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR2003-08-01
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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.