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 ID | K160455 |
| 510k Number | K160455 |
| Device Name: | AneurysmFlow |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND BV VEENPLUIS 4-6 Best, NL 5684pc |
| Contact | Jeanette Becker |
| Correspondent | Jeanette Becker PHILIPS MEDICAL SYSTEMS NEDERLAND BV VEENPLUIS 4-6 Best, NL 5684pc |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-18 |
| Decision Date | 2016-08-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838064768 | K160455 | 000 |
Trademark Results [AneurysmFlow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANEURYSMFLOW 79206337 not registered Dead/Abandoned |
Koninklijke Philips N.V. 2016-12-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.