FlexTract Deflectable-Rotational Dilator Sheath Set
FDA 510(k) K261310 · Merit Medical Systems, Inc.
510(k) numberK261310
Submission
- Device name
- FlexTract Deflectable-Rotational Dilator Sheath Set
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- April 21, 2026
- Decision date
- July 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
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| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
| K210734 | Endovascular Dilator and SetsDRE · Special | Cook Incorporated | 04/06/2021SE |
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| K242873 | Ventrax Delivery SystemDQY · Special | 01/15/2025SE |
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Questions and answers
When was FlexTract Deflectable-Rotational Dilator Sheath Set cleared by the FDA?
FlexTract Deflectable-Rotational Dilator Sheath Set (K261310) received a 510(k) decision of Substantially Equivalent on July 27, 2026, 97 days after the submission was received.
What is the product code of K261310?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.