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 the device name listed in this FDA 510(k) record. The listed applicant is Cordis US Corp. It received FDA 510(k) clearance on 2023-04-24 under 510(k) 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. The listed applicant is Cordis US Corp. The 510(k) number is K230704.

When did RAIN Sheath™ Tibial Pedal Introducer receive FDA 510(k) clearance?

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

Who is the listed applicant for RAIN Sheath™ Tibial Pedal Introducer?

The FDA 510(k) record lists Cordis US Corp as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: DYB)

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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.