AneurysmFlow

Interventional Fluoroscopic X-ray System

PHILIPS MEDICAL SYSTEMS NEDERLAND BV

The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for Aneurysmflow.

Pre-market Notification Details

Device IDK160455
510k NumberK160455
Device Name:AneurysmFlow
ClassificationInterventional Fluoroscopic X-ray System
Applicant PHILIPS MEDICAL SYSTEMS NEDERLAND BV VEENPLUIS 4-6 Best,  NL 5684pc
ContactJeanette Becker
CorrespondentJeanette Becker
PHILIPS MEDICAL SYSTEMS NEDERLAND BV VEENPLUIS 4-6 Best,  NL 5684pc
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-18
Decision Date2016-08-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838064768 K160455 000

Trademark Results [AneurysmFlow]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ANEURYSMFLOW
ANEURYSMFLOW
79206337 not registered Dead/Abandoned
Koninklijke Philips N.V.
2016-12-03

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