ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (K233904)
Description
ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ by Acist Medical Systems, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233904
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (K233904) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190473 | ACIST RXi System and Navvus II Catheter | Acist Medical Systems, Inc. | 2019 |
| K190743 | Venus Bliss | Venus Concept USA, Inc. | 2019 |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s... | Volcano Corporation | 2018 |
| K170133 | FFR V2.5 | Philips Volcano | 2017 |
| K133323 | VOLCANO IFR MODALITY | Volcano Corporation | 2014 |
| K132474 | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CA... | Acist Medical Systems | 2014 |
Trace the full predicate network for K233904
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.