Cleared Traditional

K112896 - ARRW EVOLUTION

K112896 is an FDA 510(k) clearance for ARRW EVOLUTION, manufactured by Arrow International (Subsidiary of Teleflex Inc.). The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K112896 · Arrow International (Subsidiary of Teleflex Inc.) · General Hospital
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May 2012
Decision
223d
Days
Class 2
Risk

K112896 is an FDA 510(k) clearance for the ARRW EVOLUTION. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Arrow International (Subsidiary of Teleflex Inc.) (Reading, US). The FDA issued a Cleared decision on May 10, 2012 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 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 Arrow International (Subsidiary of Teleflex Inc.) devices

FDA 510(k) Submission Details - K112896

510(k) Number K112896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date May 10, 2012
Days to Decision 223 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
94d slower than avg
Panel avg: 129d · This submission: 223d
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
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K112896.
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