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FDA 510(k)

AneurysmFlow

K-Number: K160455 · 2016-08-25

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2016-08-25
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AneurysmFlow is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K160455. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AneurysmFlow?

AneurysmFlow is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K160455.

When did AneurysmFlow receive FDA 510(k) clearance?

AneurysmFlow received FDA 510(k) clearance on 2016-08-25, under 510(k) number K160455.

Who is the listed applicant for AneurysmFlow?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AneurysmFlow?

The FDA product code for AneurysmFlow is OWB.

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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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