ViewFlex Xtra ICE Catheter— 510(k) K223077

Substantially Equivalent

Irvine Biomedical, A St. Jude Medical Company

FDA 510(k) clearance K223077 for ViewFlex Xtra ICE Catheter, Substantially Equivalent on 2022-12-07. Applicant: Irvine Biomedical, A St. Jude Medical Company.

Clearance details

Applicant: Irvine Biomedical, A St. Jude Medical Company
Product code: Code OBJ
Advisory panel: Cardiovascular
Date received: 2022-09-30
Decision date: 2022-12-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

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.