HIGH PRESSURE INJECTION LINES— 510(k) K963749

Substantially Equivalent

Maxxim Medical

FDA 510(k) clearance K963749 for HIGH PRESSURE INJECTION LINES, Substantially Equivalent on 1996-12-17. Applicant: Maxxim Medical.

Clearance details

Applicant: Maxxim Medical
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1996-09-18
Decision date: 1996-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.