RAIN Sheath Transradial
K-Number: K181592 · 2018-08-15
ApplicantCordis Corporation
Decision Date2018-08-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
RAIN Sheath Transradial is a medical device manufactured by Cordis Corporation. It received FDA 510(k) clearance on 2018-08-15 under approval number K181592. 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 Transradial?
RAIN Sheath Transradial is a medical device that received FDA 510(k) clearance on 2018-08-15. It is manufactured by Cordis Corporation. The 510(k) number is K181592.
When was RAIN Sheath Transradial approved by the FDA?
RAIN Sheath Transradial received FDA 510(k) clearance on 2018-08-15, under approval number K181592.
What company makes RAIN Sheath Transradial?
RAIN Sheath Transradial is manufactured by Cordis Corporation.
What is the FDA product code for RAIN Sheath Transradial?
The FDA product code for RAIN Sheath Transradial is 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.