FDA 510(k)

TR BAND Radial Compression Device

K-Number: K213531 · 2021-12-20

Decision Date2021-12-20

Product CodeDXC

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TR BAND Radial Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corporation. It received FDA 510(k) clearance on 2021-12-20 under 510(k) 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. The listed applicant is Terumo Medical Corporation. The 510(k) number is K213531.

When did TR BAND Radial Compression Device receive FDA 510(k) clearance?

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

Who is the listed applicant for TR BAND Radial Compression Device?

The FDA 510(k) record lists Terumo Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

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.