FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER— 510(k) K935166

Substantially Equivalent

Millar Instruments, Inc.

FDA 510(k) clearance K935166 for FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER, Substantially Equivalent on 1994-08-05. Applicant: Millar Instruments, Inc..

Clearance details

Applicant: Millar Instruments, Inc.
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 1993-10-27
Decision date: 1994-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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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.