Intri26 Introducer Sheath
FDA 510(k) K252508 · Inari Medical, Inc.
510(k) numberK252508
Submission
- Device name
- Intri26 Introducer Sheath
- Applicant
- Inari Medical, Inc.
Irvine, CA, US - Received
- August 8, 2025
- Decision date
- December 17, 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 |
|---|---|---|
| K262538 | Artix MT;Artix Thin-Walled SheathQEW · Special | 08/21/2026SE |
| K253323 | Protrieve SheathQEW · Special | 10/29/2025SE |
| K250421 | InThrill Thrombectomy SystemQEW · Traditional | 05/12/2025SE |
| K250088 | FlowTriever2 CatheterQEW · Traditional | 03/13/2025SE |
| K241894 | Artix MT; Artix Thin-Walled Thrombectomy SheathQEW · Traditional | 10/15/2024SE |
| K242557 | ClotTriever XL Catheter (41-102)QEW · Special | 09/27/2024SE |
| K233069 | Removal System Large Bore 60 cc SyringePUR · Traditional | 03/26/2024SE |
| K234034 | VenaCore Thrombectomy Catheter (46-101)QEW · Traditional | 02/09/2024SE |
| K233815 | ClotTriever SheathQEW · Special | 12/18/2023SE |
| K233646 | Intri24 Introducer Sheath (52-101)DYB · Special | 12/12/2023SE |
Questions and answers
When was Intri26 Introducer Sheath cleared by the FDA?
Intri26 Introducer Sheath (K252508) received a 510(k) decision of Substantially Equivalent on December 17, 2025, 131 days after the submission was received.
What is the product code of K252508?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.