Vado Bi-Directional Steerable Sheath
FDA 510(k) K162427 · Kalila Medical, Inc.
510(k) numberK162427
Submission
- Device name
- Vado Bi-Directional Steerable Sheath
- Applicant
- Kalila Medical, Inc.
Campbell, CA, US - Received
- August 30, 2016
- Decision date
- January 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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|---|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | Medline Industries, LP | 07/29/2026SE |
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| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
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| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
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Questions and answers
When was Vado Bi-Directional Steerable Sheath cleared by the FDA?
Vado Bi-Directional Steerable Sheath (K162427) received a 510(k) decision of Substantially Equivalent on January 27, 2017, 150 days after the submission was received.
What is the product code of K162427?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.