DUAL LUMEN CATHETER (DLC) TRAY— 510(k) K941851

Substantially Equivalent

Neostar Medical Technologies, Inc.

FDA 510(k) clearance K941851 for DUAL LUMEN CATHETER (DLC) TRAY, Substantially Equivalent on 1995-03-13. Applicant: Neostar Medical Technologies, Inc..

Clearance details

Applicant: Neostar Medical Technologies, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1994-04-14
Decision date: 1995-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brunswick, NJ, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.