Class Class II
Wallaby 017 Micro Catheter (K223139)
Description
Wallaby 017 Micro Catheter by Wallaby Medical, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223139
Clearance Date2023-04-25
Clearance TypeTraditional
Product CodeKRA
Regulation Number870.1210
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223139
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. Wallaby 017 Micro Catheter (K223139) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | 2022 |
| K042187 | ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SH... | Micro Therapeutics, Inc. | 2004 |
Trace the full predicate network for K223139
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.