IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER— 510(k) K946333

Substantially Equivalent

Irvine Biomedical, Inc.

FDA 510(k) clearance K946333 for IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER, Substantially Equivalent on 1995-07-18. Applicant: Irvine Biomedical, Inc..

Clearance details

Applicant: Irvine Biomedical, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1994-12-29
Decision date: 1995-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.