Edwards eSheath Introducer Set
FDA 510(k) K152225 · Edwards Lifesciences
510(k) numberK152225
Submission
- Device name
- Edwards eSheath Introducer Set
- Applicant
- Edwards Lifesciences
Irvine, CA, US - Received
- August 7, 2015
- Decision date
- November 24, 2015
- 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 |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…DYB · Traditional | Hartman Medical Group, LLC | 07/06/2026SE |
| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| 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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| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | 06/05/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | 04/17/2026SE |
| K253186 | HemoSphere Nano Monitor (HSNANO1)DQK · Traditional | 02/24/2026SE |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)DQK · Traditional | 12/18/2025SE |
| K253034 | HemoSphere Stream ModuleDQK · Special | 10/21/2025SE |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900)KRH · Abbreviated | 09/23/2025SE |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH · Abbreviated | 09/17/2025SE |
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Questions and answers
When was Edwards eSheath Introducer Set cleared by the FDA?
Edwards eSheath Introducer Set (K152225) received a 510(k) decision of Substantially Equivalent on November 24, 2015, 109 days after the submission was received.
What is the product code of K152225?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.