Optima Coil System— 510(k) K172390
Substantially EquivalentBlockade Medical, LLC (D.B.A. Balt Usa)
FDA 510(k) clearance K172390 for Optima Coil System, Substantially Equivalent on 2018-02-18. Applicant: Blockade Medical, LLC (D.B.A. Balt Usa).
Clearance details
- Applicant
- Blockade Medical, LLC (D.B.A. Balt Usa)
- Product code
- Code HCG
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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.