Edwards eSheath Optima introducer set
FDA 510(k) K244046 · Edwards Lifesciences
510(k) numberK244046
Submission
- Device name
- Edwards eSheath Optima introducer set
- Applicant
- Edwards Lifesciences
Irvine, CA, US - Received
- December 30, 2024
- Decision date
- March 27, 2025
- 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
Other 510(k)s with product code DYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…PZX · Traditional | 06/26/2026SE |
| K251326 | Respiration Rate algorithmBZQ · Traditional | 06/11/2026SE |
| 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 |
| K252364 | Edwards eSheath Optima introducer setDYB · Special | 08/29/2025SE |
Questions and answers
When was Edwards eSheath Optima introducer set cleared by the FDA?
Edwards eSheath Optima introducer set (K244046) received a 510(k) decision of Substantially Equivalent on March 27, 2025, 87 days after the submission was received.
What is the product code of K244046?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.