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FDA 510(k)

speX Support Catheter

K-Number: K193012 · 2020-02-19

ApplicantReflow Medical
Decision Date2020-02-19
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

speX Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Reflow Medical. It received FDA 510(k) clearance on 2020-02-19 under 510(k) number K193012. 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 speX Support Catheter?

speX Support Catheter is a medical device that received FDA 510(k) clearance on 2020-02-19. The listed applicant is Reflow Medical. The 510(k) number is K193012.

When did speX Support Catheter receive FDA 510(k) clearance?

speX Support Catheter received FDA 510(k) clearance on 2020-02-19, under 510(k) number K193012.

Who is the listed applicant for speX Support Catheter?

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

What is the FDA product code for speX Support Catheter?

The FDA product code for speX Support Catheter is DQY.

Related Clinical Trials

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.

NCT03807531A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the KneeACTIVE_NOT_RECRUITINGNCT05358353A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)COMPLETEDNCT06117150Pilot Study of the Coronary Spur Stent for In-stent Restenosis (DEEPER CORONARY)COMPLETED

Other records listing Reflow Medical 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.

K251277CoraForce Microcatheter, CoraFlex MicrocatheterK233350SINC Support CatheterK210188coraCrossK201811coraForce and coraFlex Support CathetersK200094speX LP Support CatheterK193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35

View all 12 devices →

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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