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RAIN Sheath Transradial

by Cordis Corporation

510(k) K181592

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181592 Date15 Aug 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DYB
Device class
Class II
Regulation
21 CFR Part 870.1340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The RAIN Sheath Transradial is a cardiovascular device designed for radial access procedures. It is an ultra-low profile, thin-walled introducer sheath intended to reduce the risk of radial artery trauma and spasm.

Supplied by Cordis Corporation, the device received FDA 510(k) clearance under K181592 with product code DYB. It is marketed as part of a portfolio of advanced, integrated solutions for radial access and is intended for use in transradial cardiovascular interventions.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the RAIN Sheath Transradial used for?

    The RAIN Sheath Transradial is designed for radial access procedures in transradial cardiovascular interventions. Its ultra-low profile, thin-walled construction is intended to reduce the risk of radial artery trauma and spasm during catheter insertion and manipulation.

  • How is the RAIN Sheath Transradial supplied and is it sterile?

    The RAIN Sheath Transradial is supplied by Cordis Corporation as a sterile, single-use device. It is intended for one-time use only to maintain sterility and prevent cross-contamination during transradial access procedures.

  • What regulatory pathway was used for the RAIN Sheath Transradial?

    The RAIN Sheath Transradial received FDA 510(k) clearance under submission number K181592. It was found substantially equivalent to predicate devices, with product code DYB and review by the Cardiovascular advisory committee.