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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 the device name listed in this FDA 510(k) record. The listed applicant is Cathera, Inc.. It received FDA 510(k) clearance on 2018-06-11 under 510(k) 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. The listed applicant is Cathera, Inc.. The 510(k) number is K180959.

When did Phenom 27 Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Phenom 27 Catheter?

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

What is the FDA product code for Phenom 27 Catheter?

The FDA product code for Phenom 27 Catheter is DQY.

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.

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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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