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FDA 510(k)

OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid

K-Number: K190012 · 2019-12-18

ApplicantMedtrade Product, Ltd.
Decision Date2019-12-18
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid is the device name listed in this FDA 510(k) record. The listed applicant is Medtrade Product, Ltd.. It received FDA 510(k) clearance on 2019-12-18 under 510(k) 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. The listed applicant is Medtrade Product, Ltd.. The 510(k) number is K190012.

When did OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid receive FDA 510(k) clearance?

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

Who is the listed applicant for OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid?

The FDA 510(k) record lists Medtrade Product, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: QSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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