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FDA 510(k)

Phenom Catheters

K-Number: K210230 · 2021-02-25

Decision Date2021-02-25
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Phenom Catheters is a medical device manufactured by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. It received FDA 510(k) clearance on 2021-02-25 under approval number K210230. 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 Phenom Catheters?

Phenom Catheters is a medical device that received FDA 510(k) clearance on 2021-02-25. It is manufactured by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. The 510(k) number is K210230.

When was Phenom Catheters approved by the FDA?

Phenom Catheters received FDA 510(k) clearance on 2021-02-25, under approval number K210230.

What company makes Phenom Catheters?

Phenom Catheters is manufactured by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular.

What is the FDA product code for Phenom Catheters?

The FDA product code for Phenom Catheters is DQY.

Other Devices by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

Related Devices (Code: DQY)

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.