EMBA Hourglass Peripheral Embolization Device (PED)— 510(k) K200083

Name: FDA 510(k) clearance K200083
Creator: U.S. Food and Drug Administration
Published: 2020-02-14

Substantially Equivalent

Embolic Acceleration, LLC

FDA 510(k) clearance K200083 for EMBA Hourglass Peripheral Embolization Device (PED), Substantially Equivalent on 2020-02-14. Applicant: Embolic Acceleration, LLC. Device class: 2.

Clearance details

Applicant: Embolic Acceleration, LLC
Product code: Code KRD
Device class: Class 2
Regulation: 21 CFR 870.3300
Advisory panel: Cardiovascular
Date received: 2020-01-15
Decision date: 2020-02-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KRD

product code KRD

Death: 119
Injury: 1,869
Malfunction: 7,015
Other: 1
Total: 9,004

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.