TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT— 510(k) K870412

Substantially Equivalent

Medical Surgical Concepts, Inc.

FDA 510(k) clearance K870412 for TRIPLE LUMEN INFUSION CATHETERIZATION SET OR KIT, Substantially Equivalent on 1987-05-27. Applicant: Medical Surgical Concepts, Inc..

Clearance details

Applicant: Medical Surgical Concepts, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1987-02-03
Decision date: 1987-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansdale, PA, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.