510(k) K021397— EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION

Substantially Equivalent

Biosphere Medical, Inc.

Clearance details

Applicant: Biosphere Medical, Inc.
Product code: Code NAJ
Advisory panel: Cardiovascular
Date received: 2002-05-02
Decision date: 2002-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Adverse events under product code NAJ

product code NAJ

Death: 3
Total: 3

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.