AneurysmFlow
FDA 510(k) K160455 · Philips Medical Systems Nederland B.V.
510(k) numberK160455
Submission
- Device name
- AneurysmFlow
- Applicant
- Philips Medical Systems Nederland B.V.
Best Noord-Brabant, NL - Received
- February 18, 2016
- Decision date
- August 25, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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More from Genoray Co., Ltd.
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| K253614 | EchoNavigator R5.0QIH · Traditional | 03/17/2026SE |
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| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS · Special | 01/14/2026SE |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubDQK · Abbreviated | 10/24/2025SE |
Questions and answers
When was AneurysmFlow cleared by the FDA?
AneurysmFlow (K160455) received a 510(k) decision of Substantially Equivalent on August 25, 2016, 189 days after the submission was received.
What is the product code of K160455?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.