Class Class II
ISAAC Neurovascular Navigation Catheter (K222115)
Description
ISAAC Neurovascular Navigation Catheter by MicroVention, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222115
Clearance Date2023-01-10
Clearance TypeTraditional
Product CodeDQY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222115
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. ISAAC Neurovascular Navigation Catheter (K222115) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K111380 | NEURON MAX SYSTEM | Penumbra, Inc. | 2011 |
| K082385 | CHAPERON GUIDING CATHETER | MicroVention, Inc. | 2008 |
| K083125 | NEURON SELECT CATHETER SIZE 070 | Penumbra, Inc. | 2008 |
Trace the full predicate network for K222115
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.