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FDA 510(k)

OCELOT SYSTEM

K-Number: K122380 · 2012-11-07

ApplicantAvinger, Inc.
Decision Date2012-11-07
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCELOT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Avinger, Inc.. It received FDA 510(k) clearance on 2012-11-07 under 510(k) number K122380. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCELOT SYSTEM?

OCELOT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-07. The listed applicant is Avinger, Inc.. The 510(k) number is K122380.

When did OCELOT SYSTEM receive FDA 510(k) clearance?

OCELOT SYSTEM received FDA 510(k) clearance on 2012-11-07, under 510(k) number K122380.

Who is the listed applicant for OCELOT SYSTEM?

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

What is the FDA product code for OCELOT SYSTEM?

The FDA product code for OCELOT SYSTEM is PDU.

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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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