FDA 510(k)

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter

Numéro K : K202049 · 2021-09-07

DemandeurApplied Medical Resources Corporation

Date de décision2021-09-07

Code produitDXE

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2021-09-07 under 510(k) number K202049. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter?

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter is a medical device that received FDA 510(k) clearance on 2021-09-07. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K202049.

When did Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter receive FDA 510(k) clearance?

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter received FDA 510(k) clearance on 2021-09-07, under 510(k) number K202049.

Who is the listed applicant for Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter?

The FDA product code for Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter is DXE.

Essais cliniques associés

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Autres dossiers indiquant Applied Medical Resources Corporation en tant que demandeur

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Source officielle

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