Cleared Traditional

K143604 - Alvision Interventional Cardiology Diag...

K143604 is an FDA 510(k) clearance for Alvision Interventional Cardiology Diag..., manufactured by Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K143604 · Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2015
Decision
189d
Days
Class 2
Risk

K143604 is an FDA 510(k) clearance for the Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular.... Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S (Catalca, TR). The FDA issued a Cleared decision on June 25, 2015 after a review of 189 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S devices

FDA 510(k) Submission Details - K143604

510(k) Number K143604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date June 25, 2015
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 125d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 356
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K143604.
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