VYGON STOPCOCKS & RAMPS(MANIFOLDS)— 510(k) K813141

Substantially Equivalent

Exco, Inc.

FDA 510(k) clearance K813141 for VYGON STOPCOCKS & RAMPS(MANIFOLDS), Substantially Equivalent on 1981-11-27. Applicant: Exco, Inc..

Clearance details

Applicant: Exco, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1981-11-05
Decision date: 1981-11-27
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.