Class Class II
Aspira Pleural Drainage System (K212696)
Description
Aspira Pleural Drainage System by Merit Medical Systems, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK212696
Clearance Date2023-03-03
Clearance TypeTraditional
Product CodeDWM
Regulation Number870.5050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K212696
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. Aspira Pleural Drainage System (K212696) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201155 | PleurX Peritoneal Catheter System | Care Fusion | 2020 |
| K160450 | Pleurx Pleural Catheter System | Care Fusion | 2016 |
| K110409 | ASPIRA PLEURAL DRAINAGE SYSTEM | C.R. Bard, Inc. | 2011 |
Trace the full predicate network for K212696
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.