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510(k) K201695

Patent Hemostasis Band (PH Band) by Medical Ingenuities — Product Code DXC

K201695 is an FDA 510(k) premarket notification submitted by Medical Ingenuities for the device "Patent Hemostasis Band (PH Band)". The FDA issued a decision of Substantially Equivalent on October 30, 2020. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2020
Date Received
June 22, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

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FDA data resources