510(k) K160455 ยท OWB Interventional Fluoroscopic X-Ray System
AneurysmFlow
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Aug 25, 2016 |
| Received | Feb 18, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K160455
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips AneurysmFlow. Model Number: 001015.
AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA dat Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.