Vado Bi-Directional Steerable Sheath
K-Number: K162427 · 2017-01-27
ApplicantKalila Medical, Inc.
Decision Date2017-01-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Vado Bi-Directional Steerable Sheath is a medical device manufactured by Kalila Medical, Inc.. It received FDA 510(k) clearance on 2017-01-27 under approval number K162427. 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 Vado Bi-Directional Steerable Sheath?
Vado Bi-Directional Steerable Sheath is a medical device that received FDA 510(k) clearance on 2017-01-27. It is manufactured by Kalila Medical, Inc.. The 510(k) number is K162427.
When was Vado Bi-Directional Steerable Sheath approved by the FDA?
Vado Bi-Directional Steerable Sheath received FDA 510(k) clearance on 2017-01-27, under approval number K162427.
What company makes Vado Bi-Directional Steerable Sheath?
Vado Bi-Directional Steerable Sheath is manufactured by Kalila Medical, Inc..
What is the FDA product code for Vado Bi-Directional Steerable Sheath?
The FDA product code for Vado Bi-Directional Steerable Sheath is DYB.
Other Devices by Kalila Medical, Inc.
Related Devices (Code: DYB)
K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC
K162097InTRAkitMedtronic Vascular
K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc.
K153771TXM Guiding SheathTexasmedical Technologies, Inc.
K162184Edwards eSheath Introducer SetEdward Lifesciences
K153494HQS Introducer (Model 2064-HQS)Alseal
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.