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FDA 510(k)

FlexTract Deflectable-Rotational Dilator Sheath Set

K-Number: K261310 · 2026-07-27

ApplicantMerit Medical Systems, Inc.
Decision Date2026-07-27
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlexTract Deflectable-Rotational Dilator Sheath Set is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-07-27 under 510(k) number K261310. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlexTract Deflectable-Rotational Dilator Sheath Set?

FlexTract Deflectable-Rotational Dilator Sheath Set is a medical device that received FDA 510(k) clearance on 2026-07-27. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K261310.

When did FlexTract Deflectable-Rotational Dilator Sheath Set receive FDA 510(k) clearance?

FlexTract Deflectable-Rotational Dilator Sheath Set received FDA 510(k) clearance on 2026-07-27, under 510(k) number K261310.

Who is the listed applicant for FlexTract Deflectable-Rotational Dilator Sheath Set?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlexTract Deflectable-Rotational Dilator Sheath Set?

The FDA product code for FlexTract Deflectable-Rotational Dilator Sheath Set is DRE.

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Related Devices (Code: DRE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K232609Micro Ace™ Advanced Micro Access SystemMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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