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FDA 510(k)

CLEARWAY OTW MODEL 85912

K-Number: K093431 · 2010-04-20

ApplicantAtrium Medical Corp.
Decision Date2010-04-20
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLEARWAY OTW MODEL 85912 is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 2010-04-20 under 510(k) number K093431. 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 CLEARWAY OTW MODEL 85912?

CLEARWAY OTW MODEL 85912 is a medical device that received FDA 510(k) clearance on 2010-04-20. The listed applicant is Atrium Medical Corp.. The 510(k) number is K093431.

When did CLEARWAY OTW MODEL 85912 receive FDA 510(k) clearance?

CLEARWAY OTW MODEL 85912 received FDA 510(k) clearance on 2010-04-20, under 510(k) number K093431.

Who is the listed applicant for CLEARWAY OTW MODEL 85912?

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

What is the FDA product code for CLEARWAY OTW MODEL 85912?

The FDA product code for CLEARWAY OTW MODEL 85912 is DQY.

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Other records listing Atrium Medical Corp. as applicant

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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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