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FDA 510(k)

FieldFlex Steerable Sheath

K-Number: K261492 · 2026-06-05

ApplicantCenterPoint Systems, LLC
Decision Date2026-06-05
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FieldFlex Steerable Sheath is the device name listed in this FDA 510(k) record. The listed applicant is CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K261492. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FieldFlex Steerable Sheath?

FieldFlex Steerable Sheath is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is CenterPoint Systems, LLC. The 510(k) number is K261492.

When did FieldFlex Steerable Sheath receive FDA 510(k) clearance?

FieldFlex Steerable Sheath received FDA 510(k) clearance on 2026-06-05, under 510(k) number K261492.

Who is the listed applicant for FieldFlex Steerable Sheath?

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

What is the FDA product code for FieldFlex Steerable Sheath?

The FDA product code for FieldFlex Steerable Sheath is DYB.

Other records listing CenterPoint Systems, LLC as applicant

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.

K260942AuST Steerable SheathK260163AuST CSP IntroducerK250147CPS Locator 3D Delivery CatheterK250828CPS Locator 3D Plus Delivery CatheterK250492FlexiGo 3D Delivery CatheterK251051AuST Steerable Sheath

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Related Devices (Code: DYB)

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.

K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK260606Echo Large Bore Introducer SheathEcho Medical, LLCK254248Introducer Sheath SetCardiocycle Medical(Suzhou) Co., Ltd.K254279Edwards eSheath+ introducer setEdwards Lifesciences

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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