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FDA 510(k)

Wingman 18 Crossing Catheter

K-Number: K160848 · 2016-07-14

ApplicantReflow Medical, Inc.
Decision Date2016-07-14
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wingman 18 Crossing Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Reflow Medical, Inc.. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K160848. 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 Wingman 18 Crossing Catheter?

Wingman 18 Crossing Catheter is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Reflow Medical, Inc.. The 510(k) number is K160848.

When did Wingman 18 Crossing Catheter receive FDA 510(k) clearance?

Wingman 18 Crossing Catheter received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160848.

Who is the listed applicant for Wingman 18 Crossing Catheter?

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

What is the FDA product code for Wingman 18 Crossing Catheter?

The FDA product code for Wingman 18 Crossing Catheter is DQY.

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Other records listing Reflow Medical, Inc. 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

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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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