ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES— 510(k) K042297
Substantially EquivalentActa Vascular Systems, Inc.
FDA 510(k) clearance K042297 for ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES, Substantially Equivalent on 2005-06-01. Applicant: Acta Vascular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Acta Vascular Systems, 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
- Abbreviated
- Location
- Los Gatos, CA, US
Recent devices under product code HCG
view allAdverse 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.