extriCARE 1000 Negative Pressure Wound Therapy System (K213906)
Description
extriCARE 1000 Negative Pressure Wound Therapy System by Alleva Medical, Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213906
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. extriCARE 1000 Negative Pressure Wound Therapy System (K213906) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191760 | PICO 14 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2019 |
| K142916 | SVED Wound Treatment System | Cardinalhealth | 2015 |
| K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump an... | Devon Medical, Inc. | 2014 |
Trace the full predicate network for K213906
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.