510(k) Report

Devices descending from K133700

4 later devices reach Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243412ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)20251—
+1K223592Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System…Boston Scientific Corporation202211
+2K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)20260—
+2K251291Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System…Boston Scientific20250—