Barricade Embolization Coil System— 510(k) K151760

Substantially Equivalent

Blockade Medical

FDA 510(k) clearance K151760 for Barricade Embolization Coil System, Substantially Equivalent on 2015-07-27. Applicant: Blockade Medical.

Clearance details

Applicant
Blockade Medical
Product code
Code HCG
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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.