Vado Steerable Sheath

FDA 510(k) K160721 · Kalila Medical, Inc.

Substantially Equivalent

510(k) numberK160721

Submission

Device name
Vado Steerable Sheath
Applicant
Kalila Medical, Inc.
Campbell, CA, US
Received
March 16, 2016
Decision date
March 7, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DYB – Introducer, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1340
Specialty
Cardiovascular

Other 510(k)s with product code DYB

510(k)DeviceApplicantDecision
K253526NAMIC Dilator and SheathDYB · Traditional Medline Industries, LP07/29/2026SE
K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…DYB · Traditional Hartman Medical Group, LLC07/06/2026SE
K261242SimplGuideDYB · Traditional Pendracare06/25/2026SE
K261950Health Line Tearaway IntroducerDYB · Traditional Health Line International Corporation06/22/2026SE
K261492FieldFlex Steerable SheathDYB · Special CenterPoint Systems, LLC06/05/2026SE
K260606Echo Large Bore Introducer SheathDYB · Traditional Echo Medical, LLC04/29/2026SE
K254248Introducer Sheath SetDYB · Traditional Cardiocycle Medical(Suzhou) Co., Ltd.04/23/2026SE
K254279Edwards eSheath+ introducer setDYB · Traditional Edwards Lifesciences04/17/2026SE
K260091Aventus Introducer SheathDYB · Traditional Inquis Medical04/13/2026SE
K260839Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional Protaryx Medical, Inc.04/10/2026SE

More from Protaryx Medical, Inc.

510(k)DeviceDecision
K162427Vado Bi-Directional Steerable SheathDYB · Traditional 01/27/2017SE
K140420Vado Steerable SheathDYB · Traditional 04/01/2014SE

Questions and answers

When was Vado Steerable Sheath cleared by the FDA?

Vado Steerable Sheath (K160721) received a 510(k) decision of Substantially Equivalent on March 7, 2017, 356 days after the submission was received.

What is the product code of K160721?

The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.