VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS— 510(k) K052475

Substantially Equivalent

Vygon Us, LLC

FDA 510(k) clearance K052475 for VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS, Substantially Equivalent on 2006-09-14. Applicant: Vygon Us, LLC.

Clearance details

Applicant: Vygon Us, LLC
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2005-09-09
Decision date: 2006-09-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Norristown, PA, US

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Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.