VIEWFLEX XTRA ICE CATHETER— 510(k) K121381

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K121381 for VIEWFLEX XTRA ICE CATHETER, Substantially Equivalent on 2012-06-07. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: Code IYO
Advisory panel: Radiology
Date received: 2012-05-08
Decision date: 2012-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.