Cleared Special

VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS (K052475) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052475 · Vygon Us, LLC · General Hospital
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Sep 2006
Decision
370d
Days
Class 2
Risk

K052475 is an FDA 510(k) clearance for the VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Vygon Us, LLC (Norristown, US). The FDA issued a Cleared decision on September 14, 2006 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vygon Us, LLC devices

Submission Details

510(k) Number K052475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2005
Decision Date September 14, 2006
Days to Decision 370 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
241d slower than avg
Panel avg: 129d · This submission: 370d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

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