FDA 510(k)

RAIN Sheath Tibial Pedal Introducer

K-Number: K230704 · 2023-04-24

Decision Date2023-04-24

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

RAIN Sheath Tibial Pedal Introducer is a medical device manufactured by Cordis US Corp. It received FDA 510(k) clearance on 2023-04-24 under approval number K230704. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAIN Sheath Tibial Pedal Introducer?

RAIN Sheath Tibial Pedal Introducer is a medical device that received FDA 510(k) clearance on 2023-04-24. It is manufactured by Cordis US Corp. The 510(k) number is K230704.

When was RAIN Sheath Tibial Pedal Introducer approved by the FDA?

RAIN Sheath Tibial Pedal Introducer received FDA 510(k) clearance on 2023-04-24, under approval number K230704.

What company makes RAIN Sheath Tibial Pedal Introducer?

RAIN Sheath Tibial Pedal Introducer is manufactured by Cordis US Corp.

What is the FDA product code for RAIN Sheath Tibial Pedal Introducer?

The FDA product code for RAIN Sheath Tibial Pedal Introducer is DYB.

Other Devices by Cordis US Corp

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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.