FlexTract Deflectable-Rotational Dilator Sheath Set— 510(k) K261310
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K261310 for FlexTract Deflectable-Rotational Dilator Sheath Set, Substantially Equivalent on 2026-07-27. Applicant: Merit Medical Systems, Inc.. Device class: 2.
Summary
Merit Medical Systems' FlexTract Deflectable-Rotational Dilator Sheath Set is filed under DRE, vessel dilators for percutaneous catheterization. The record doesn't give sizes or list what's in the set.
Class II, 21 CFR 870.1310. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Merit Medical filed from South Jordan, Utah. Review took 97 calendar days (April 21 to July 27, 2026).
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Product code DRE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
Recent devices under product code DRE
view allMore clearances from Merit Medical Systems, Inc.
view allAdverse events under product code DRE
product code DRE- Death
- 100
- Injury
- 832
- Malfunction
- 597
- Other
- 3
- Total
- 1,532
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.