Edwards eSheath+ introducer set
FDA 510(k) K254279 · Edwards Lifesciences
510(k) numberK254279
Submission
- Device name
- Edwards eSheath+ introducer set
- Applicant
- Edwards Lifesciences
Irvine, CA, US - Received
- December 30, 2025
- Decision date
- April 17, 2026
- 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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| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
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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 |
| 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 |
| K260942 | AuST Steerable SheathDYB · Special | CenterPoint Systems, LLC | 04/07/2026SE |
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| K253034 | HemoSphere Stream ModuleDQK · Special | 10/21/2025SE |
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Questions and answers
When was Edwards eSheath+ introducer set cleared by the FDA?
Edwards eSheath+ introducer set (K254279) received a 510(k) decision of Substantially Equivalent on April 17, 2026, 108 days after the submission was received.
What is the product code of K254279?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.