Cleared Abbreviated

K113124 - ALN OPTIONAL VANA CAVA FILTER (FDA 510(k) Clearance)

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

K113124 · Aln Implants Chirurgicaux · Cardiovascular device
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Nov 2012
Decision
385d
Days
Class 2
Risk

K113124 is an FDA 510(k) clearance for the ALN OPTIONAL VANA CAVA FILTER. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Aln Implants Chirurgicaux (Jarnac, FR). The FDA issued a Cleared decision on November 9, 2012 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - the FDA cardiovascular device oversight 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 Aln Implants Chirurgicaux devices

Submission Details

510(k) Number K113124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2011
Decision Date November 09, 2012
Days to Decision 385 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
260d slower than avg
Panel avg: 125d · This submission: 385d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DTK Filter, Intravascular, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3375
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTK Filter, Intravascular, Cardiovascular

All 82
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