Vado Steerable Sheath

FDA 510(k) K140420 · Kalila Medical, Inc.

Substantially Equivalent

510(k) numberK140420

Submission

Device name
Vado Steerable Sheath
Applicant
Kalila Medical, Inc.
Campbell, CA, US
Received
February 18, 2014
Decision date
April 1, 2014
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

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Questions and answers

When was Vado Steerable Sheath cleared by the FDA?

Vado Steerable Sheath (K140420) received a 510(k) decision of Substantially Equivalent on April 1, 2014, 42 days after the submission was received.

What is the product code of K140420?

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