Cleared Abbreviated

K141634 - NAUTILUS DELTA (FDA 510(k) Clearance)

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

K141634 · Romedex International Srl · General Hospital
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Jan 2015
Decision
223d
Days
Class 2
Risk

K141634 is an FDA 510(k) clearance for the NAUTILUS DELTA. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Romedex International Srl (San Francisco, US). The FDA issued a Cleared decision on January 27, 2015 after a review of 223 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Romedex International Srl devices

Submission Details

510(k) Number K141634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2014
Decision Date January 27, 2015
Days to Decision 223 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 128d · This submission: 223d
Pathway characteristics
Standards-based clearance path.

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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