Cleared Traditional

K093775 - EVGUIDE TIP LOCATION SYSTEM

K093775 is an FDA 510(k) clearance for EVGUIDE TIP LOCATION SYSTEM, manufactured by Romedex International Srl. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K093775 · Romedex International Srl · General Hospital
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Jul 2010
Decision
219d
Days
Class 2
Risk

K093775 is an FDA 510(k) clearance for the EVGUIDE TIP LOCATION SYSTEM. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Romedex International Srl (Palo Alto, US). The FDA issued a Cleared decision on July 15, 2010 after a review of 219 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 Romedex International Srl devices

FDA 510(k) Submission Details - K093775

510(k) Number K093775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2009
Decision Date July 15, 2010
Days to Decision 219 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
90d slower than avg
Panel avg: 129d · This submission: 219d
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 209
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