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FDA 510(k)

Vado Steerable Sheath

K-Number: K160721 · 2017-03-07

ApplicantKalila Medical, Inc.
Decision Date2017-03-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vado 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 2017-03-07 under 510(k) number K160721. 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 Steerable Sheath?

Vado Steerable Sheath is a medical device that received FDA 510(k) clearance on 2017-03-07. The listed applicant is Kalila Medical, Inc.. The 510(k) number is K160721.

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

Vado Steerable Sheath received FDA 510(k) clearance on 2017-03-07, under 510(k) number K160721.

Who is the listed applicant for Vado 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 Steerable Sheath?

The FDA product code for Vado 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.

K162427Vado Bi-Directional 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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