FDA 510(k)

Patent Hemostasis Band (PH Band)

K-Number: K201695 · 2020-10-30

Decision Date2020-10-30

Product CodeDXC

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Patent Hemostasis Band (PH Band) is a medical device manufactured by Medical Ingenuities. It received FDA 510(k) clearance on 2020-10-30 under approval number K201695. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patent Hemostasis Band (PH Band)?

Patent Hemostasis Band (PH Band) is a medical device that received FDA 510(k) clearance on 2020-10-30. It is manufactured by Medical Ingenuities. The 510(k) number is K201695.

When was Patent Hemostasis Band (PH Band) approved by the FDA?

Patent Hemostasis Band (PH Band) received FDA 510(k) clearance on 2020-10-30, under approval number K201695.

What company makes Patent Hemostasis Band (PH Band)?

Patent Hemostasis Band (PH Band) is manufactured by Medical Ingenuities.

What is the FDA product code for Patent Hemostasis Band (PH Band)?

The FDA product code for Patent Hemostasis Band (PH Band) is DXC.

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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.