K101239

Substantially Equivalent

VIEWFLEX PLUS ICE CATHETER

Applicant: St Jude Medical
Product code: DQO
Advisory panel: Cardiovascular
Date received: 2010-05-03
Decision date: 2010-06-02
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.