Talon Transseptal Sheath
FDA 510(k) K231108 · Inari Medical, Inc.
510(k) numberK231108
Submission
- Device name
- Talon Transseptal Sheath
- Applicant
- Inari Medical, Inc.
Irvine, CA, US - Received
- April 19, 2023
- Decision date
- September 27, 2023
- 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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| 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 |
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More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262538 | Artix MT;Artix Thin-Walled SheathQEW · Special | 08/21/2026SE |
| K252508 | Intri26 Introducer SheathDYB · Traditional | 12/17/2025SE |
| 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 |
Questions and answers
When was Talon Transseptal Sheath cleared by the FDA?
Talon Transseptal Sheath (K231108) received a 510(k) decision of Substantially Equivalent on September 27, 2023, 161 days after the submission was received.
What is the product code of K231108?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.