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FDA 510(k)

TR BAND Radial Compression Device

K-Number: K213531 · 2021-12-20

ApplicantTerumo Medical Corporation
Decision Date2021-12-20
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TR BAND Radial Compression Device is a medical device manufactured by Terumo Medical Corporation. It received FDA 510(k) clearance on 2021-12-20 under approval number K213531. 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 TR BAND Radial Compression Device?

TR BAND Radial Compression Device is a medical device that received FDA 510(k) clearance on 2021-12-20. It is manufactured by Terumo Medical Corporation. The 510(k) number is K213531.

When was TR BAND Radial Compression Device approved by the FDA?

TR BAND Radial Compression Device received FDA 510(k) clearance on 2021-12-20, under approval number K213531.

What company makes TR BAND Radial Compression Device?

TR BAND Radial Compression Device is manufactured by Terumo Medical Corporation.

What is the FDA product code for TR BAND Radial Compression Device?

The FDA product code for TR BAND Radial Compression Device is DXC.

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Official Source

View on FDA Database →

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

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