K111854

Substantially Equivalent

AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER

Applicant: St. Jude Medical Systems AB
Product code: DRG
Advisory panel: Cardiovascular
Date received: 2011-06-29
Decision date: 2011-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.