TRANSPARENT MANIFOLD— 510(k) K772299

Substantially Equivalent

Uni-Research

FDA 510(k) clearance K772299 for TRANSPARENT MANIFOLD, Substantially Equivalent on 1977-12-21. Applicant: Uni-Research.

Clearance details

Applicant: Uni-Research
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1977-12-13
Decision date: 1977-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.