INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER— 510(k) K042775

Substantially Equivalent

Irvine Biomedical, Inc.

FDA 510(k) clearance K042775 for INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER, Substantially Equivalent on 2004-11-04. Applicant: Irvine Biomedical, Inc..

Clearance details

Applicant: Irvine Biomedical, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2004-10-06
Decision date: 2004-11-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.