510(k) Report

FDA applicant

Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S

Catalca, TR2 decisions2014–20150 recalls

FDA records 2 decisions for Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S (Catalca, TR) from 2014 to 2015: 2 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and DQY (Catheter, Percutaneous). Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQOCatheter, Intravascular, Diagnostic1decision
  • DQYCatheter, Percutaneous1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K143604Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic CathetersAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · 2015
  • K141529Alviguide Blue+ Interventional Cardiology Guiding CatheterAlvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S · 2014

All 2 as Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S →