ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE— 510(k) K130307

Substantially Equivalent

Celonova Biosciences, Inc.

FDA 510(k) clearance K130307 for ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE, Substantially Equivalent on 2013-03-04. Applicant: Celonova Biosciences, Inc..

Clearance details

Applicant: Celonova Biosciences, Inc.
Product code: Code KRD
Advisory panel: Cardiovascular
Date received: 2013-02-07
Decision date: 2013-03-04
Decision: Substantially Equivalent
Clearance type: Special
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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.