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FDA 510(k)

Phenom 27 Catheter

K-Number: K180959 · 2018-06-11

ApplicantCathera, Inc.
Decision Date2018-06-11
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Phenom 27 Catheter is a medical device manufactured by Cathera, Inc.. It received FDA 510(k) clearance on 2018-06-11 under approval number K180959. 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 27 Catheter?

Phenom 27 Catheter is a medical device that received FDA 510(k) clearance on 2018-06-11. It is manufactured by Cathera, Inc.. The 510(k) number is K180959.

When was Phenom 27 Catheter approved by the FDA?

Phenom 27 Catheter received FDA 510(k) clearance on 2018-06-11, under approval number K180959.

What company makes Phenom 27 Catheter?

Phenom 27 Catheter is manufactured by Cathera, Inc..

What is the FDA product code for Phenom 27 Catheter?

The FDA product code for Phenom 27 Catheter is DQY.

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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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