Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Kalila Medical, Inc.. It received FDA 510(k) clearance on 2017-01-27 under 510(k) 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. The listed applicant is Kalila Medical, Inc.. The 510(k) number is K162427.

When did Vado Bi-Directional Steerable Sheath receive FDA 510(k) clearance?

Vado Bi-Directional Steerable Sheath received FDA 510(k) clearance on 2017-01-27, under 510(k) number K162427.

Who is the listed applicant for Vado Bi-Directional Steerable Sheath?

The FDA 510(k) record lists Kalila Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Kalila Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160721Vado Steerable Sheath

Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.

↑