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FDA 510(k)

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

K-Number: K202049 · 2021-09-07

ApplicantApplied Medical Resources Corporation
Decision Date2021-09-07
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Applied Medical Resources Corporation. The 510(k) number is K202049.

When was Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter approved by the FDA?

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

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

Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter is manufactured by Applied Medical Resources Corporation.

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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