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FDA 510(k)

FlexiGo 3D Delivery Catheter

K-Number: K250492 · 2025-06-18

ApplicantCenterPoint Systems, LLC
Decision Date2025-06-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlexiGo 3D Delivery Catheter 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 2025-06-18 under 510(k) number K250492. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlexiGo 3D Delivery Catheter?

FlexiGo 3D Delivery Catheter is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is CenterPoint Systems, LLC. The 510(k) number is K250492.

When did FlexiGo 3D Delivery Catheter receive FDA 510(k) clearance?

FlexiGo 3D Delivery Catheter received FDA 510(k) clearance on 2025-06-18, under 510(k) number K250492.

Who is the listed applicant for FlexiGo 3D Delivery Catheter?

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 FlexiGo 3D Delivery Catheter?

The FDA product code for FlexiGo 3D Delivery Catheter is DQY.

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.

K262240SSPC NXT Delivery CatheterK261766CPS Locator 3D Plus Delivery CatheterK261492FieldFlex Steerable SheathK260942AuST Steerable SheathK260163AuST CSP IntroducerK250147CPS Locator 3D Delivery Catheter

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Related Devices (Code: DQY)

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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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