CLEANER ROTATIONAL THROMBECTOMY SYSTEM— 510(k) K120346

Name: FDA 510(k) clearance K120346
Creator: U.S. Food and Drug Administration
Published: 2012-06-01

Substantially Equivalent

Rex Medical

FDA 510(k) clearance K120346 for CLEANER ROTATIONAL THROMBECTOMY SYSTEM, Substantially Equivalent on 2012-06-01. Applicant: Rex Medical. Device class: 2.

Clearance details

Applicant: Rex Medical
Product code: Code MCW
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 2012-02-03
Decision date: 2012-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.