FDA 510(k)

OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid

K-Number: K190012 · 2019-12-18

Decision Date2019-12-18

Product CodeQSY

DecisionSubstantially Equivalent

Device Summary

OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid is a medical device manufactured by Medtrade Product, Ltd.. It received FDA 510(k) clearance on 2019-12-18 under approval number K190012. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid?

OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid is a medical device that received FDA 510(k) clearance on 2019-12-18. It is manufactured by Medtrade Product, Ltd.. The 510(k) number is K190012.

When was OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid approved by the FDA?

OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid received FDA 510(k) clearance on 2019-12-18, under approval number K190012.

What company makes OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid?

OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid is manufactured by Medtrade Product, Ltd..

What is the FDA product code for OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid?

The FDA product code for OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid is QSY.

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Official Source

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