510(k) Report

Devices descending from K944290

27 later devices reach Catheters, Biliary Catheters, Urological through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…Boston Scientific Corporation202205
+1K191446Ureteral Stent Systems, Biliary Drainage CathetersBoston Scientific Corporation20200—
+1K141335Expel Apd Drainage Catheter SystemBoston Scientific Corp201412
+1K093392Multipurpose, Nephrostomy and Biliary Drainage CathetersNavilyst Medical, Inc.200953
+1K965147Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp19971723
+2K181669ConvertX Biliary Stent SystemBrightwater Medical20190—
+2K152069Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage…Navilyst Medical, Inc.20152—
+2K111315Multipurpose Drainage CatheterNavilyst Medical, Inc.20110—
+2K103353Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary Drainage CatheterNavilyst Medical, Inc.20111—
+2K101314Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp201014—
+2K101786Advanix Double Pigtail Biliary StentBoston Scientific Corp20101—
+3K203162Advanix Biliary Stent with NaviFlex RX Delivery SystemBoston Scientific Corporation20201—
+3K193600EndoGI Biliary Stent SystemEndogi Medical, Ltd.20203—
+3K173035Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter…Cook Incorporated201813
+3K140630Wallflex Biliary RX Stent SystemBoston Scientific201431
+3K133700Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and…Boston Scientific Corporation2014413
+4K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)20260—
+4K243412ARCHIMEDES Biodegradable Pancreatic StentQ3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)20251—
+4K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific20241—
+4K232596EndoGI S-Path Biliary Stent SystemEndogi Medical, Ltd.20230—
+4K223469WallFlex™ Biliary RX Stent SystemBoston Scientific Corporation20231—
+4K223592Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System…Boston Scientific Corporation202211
+4K202477EndoGI S-Path Biliary Stent SystemEndo GI Medical20202—
+4K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…Cook Incorporated20200—
+5K251291Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System…Boston Scientific20250—
+5K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific20240—
+5K222627EndoGI S-Path Biliary Stent SystemEndo GI Medical20221—