K151187

Substantially Equivalent

QuadraSphere Microspheres

Applicant: Biosphere Medical, S.A.
Product code: KRD
Advisory panel: Cardiovascular
Date received: 2015-05-04
Decision date: 2015-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roissy-En-France, FR

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.