Cleared Traditional

K110627 - NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER

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
Combination Product No
PCCP Authorized No
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 279
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K110627.
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