MEDCOMP DISPOSABLE MANIFOLD SYSTEM— 510(k) K863661

Substantially Equivalent

Medical Components, Inc.

FDA 510(k) clearance K863661 for MEDCOMP DISPOSABLE MANIFOLD SYSTEM, Substantially Equivalent on 1986-09-29. Applicant: Medical Components, Inc..

Clearance details

Applicant: Medical Components, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1986-09-18
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harleysville, PA, 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.