Cleared Traditional

K110627 - NEXSITE 9FR DUAL LUMEN CRITICAL CARE CE...

K110627 is an FDA 510(k) clearance for NEXSITE 9FR DUAL LUMEN CRITICAL CARE CE..., manufactured by Marvao Medical Devices, Ltd.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K110627 · Marvao Medical Devices, Ltd. · General Hospital
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Aug 2011
Decision
161d
Days
Class 2
Risk

K110627 is an FDA 510(k) clearance for the NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Marvao Medical Devices, Ltd. (Northborough, US). The FDA issued a Cleared decision on August 12, 2011 after a review of 161 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Marvao Medical Devices, Ltd. devices

FDA 510(k) Submission Details - K110627

510(k) Number K110627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2011
Decision Date August 12, 2011
Days to Decision 161 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 129d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

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

All 194
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K110627.
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