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FDA 510(k)

AneurysmFlow

K-Number: K160455 · 2016-08-25

Decision Date2016-08-25
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AneurysmFlow is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-08-25 under approval 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. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K160455.

When was AneurysmFlow approved by the FDA?

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

What company makes AneurysmFlow?

AneurysmFlow is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for AneurysmFlow?

The FDA product code for AneurysmFlow is OWB.

Other Devices by Philips Medical Systems Nederland B.V.

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Related Devices (Code: OWB)

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.