ARCHIMEDES Biodegradable Pancreatic Stent (K243412)
Description
ARCHIMEDES Biodegradable Pancreatic Stent by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.), an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243412
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. ARCHIMEDES Biodegradable Pancreatic Stent (K243412) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K133700 | ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCRE... | Boston Scientific Corporation | 2014 |
| K013784 | URETERAL STENT | Boston Scientific Corp | 2002 |
Trace the full predicate network for K243412
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.