EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION— 510(k) K021397
Substantially EquivalentBiosphere Medical, Inc.
FDA 510(k) clearance K021397 for EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION, Substantially Equivalent on 2002-11-22. Applicant: Biosphere Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Biosphere Medical, Inc.
- Product code
- Code NAJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
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More clearances from Biosphere Medical, Inc.
view allAdverse events under product code NAJ
product code NAJ- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . 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.