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

Name: FDA 510(k) clearance K042775
Creator: U.S. Food and Drug Administration
Published: 2004-11-04

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.. Device class: 2.

Clearance details

Applicant: Irvine Biomedical, Inc.
Product code: Code DRF
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 2004-10-06
Decision date: 2004-11-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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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.