Introducer Sheath Set
FDA 510(k) K254248 · Cardiocycle Medical(Suzhou) Co., Ltd.
510(k) numberK254248
Submission
- Device name
- Introducer Sheath Set
- Applicant
- Cardiocycle Medical(Suzhou) Co., Ltd.
Suzhou, Jiangsu, CN - Received
- December 29, 2025
- Decision date
- April 23, 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
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 |
| 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 |
| K260942 | AuST Steerable SheathDYB · Special | CenterPoint Systems, LLC | 04/07/2026SE |
More from CenterPoint Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K251838 | Introducer Sheath SetDYB · Traditional | 10/21/2025SE |
Questions and answers
When was Introducer Sheath Set cleared by the FDA?
Introducer Sheath Set (K254248) received a 510(k) decision of Substantially Equivalent on April 23, 2026, 115 days after the submission was received.
What is the product code of K254248?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.