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510(k) K190012

OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid by Medtrade Product, Ltd. — Product Code QSY

K190012 is an FDA 510(k) premarket notification submitted by Medtrade Product, Ltd. for the device "OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid". The FDA issued a decision of Substantially Equivalent on December 18, 2019. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2019
Date Received
January 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

To temporarily control bleeding and cover external wounds.

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FDA data resources