MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.— 510(k) K812944

Substantially Equivalent

Millar Instruments, Inc.

FDA 510(k) clearance K812944 for MILLAR MIKRO-TIP CATHETER PRESSURE TRAN., Substantially Equivalent on 1981-11-16. Applicant: Millar Instruments, Inc..

Clearance details

Applicant: Millar Instruments, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1981-10-20
Decision date: 1981-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.