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FDA 510(k)

React 71 Catheter

K-Number: K241177 · 2024-05-28

ApplicantMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Decision Date2024-05-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

React 71 Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. It received FDA 510(k) clearance on 2024-05-28 under 510(k) number K241177. 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 React 71 Catheter?

React 71 Catheter is a medical device that received FDA 510(k) clearance on 2024-05-28. The listed applicant is Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. The 510(k) number is K241177.

When did React 71 Catheter receive FDA 510(k) clearance?

React 71 Catheter received FDA 510(k) clearance on 2024-05-28, under 510(k) number K241177.

Who is the listed applicant for React 71 Catheter?

The FDA 510(k) record lists Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for React 71 Catheter?

The FDA product code for React 71 Catheter is DQY.

Other records listing Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular 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.

K233420Axium Detachable Coil; Axium Prime Detachable CoilK210230Phenom Catheters

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

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

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