CARDIA-CATH— 510(k) K112323

Substantially Equivalent

Millar Instruments, Inc.

FDA 510(k) clearance K112323 for CARDIA-CATH, Substantially Equivalent on 2011-10-18. Applicant: Millar Instruments, Inc..

Clearance details

Applicant: Millar Instruments, Inc.
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 2011-08-12
Decision date: 2011-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.