Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (K250610)
Description
Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) by Sorin Group Italia S.R.L., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250610
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. Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (K250610) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K091542 | ESTECH EASYFLOW CANNULA WITH GUIDEWIRE | Endoscopic Technologies, Inc. D/B/A... | 2009 |
| K060101 | ESTECH AORTIC EASY FLOW CANNULA | Endoscopic Technologies, Inc. | 2006 |
Trace the full predicate network for K250610
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.