QUADRASPHERE 30 TO 60— 510(k) K113822
Substantially EquivalentBiosphere Medical, Inc.
FDA 510(k) clearance K113822 for QUADRASPHERE 30 TO 60, Substantially Equivalent on 2012-03-08. Applicant: Biosphere Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Biosphere Medical, Inc.
- Product code
- Code HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rockland, MA, US
Recent devices under product code HCG
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- K062126 — EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
- K061171 — SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
- K021397 — EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION
- K010026 — EMBOGOLD MICROSPHERE
Adverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
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.