510(k) Report

Devices descending from K032393

18 later devices reach Induction and Sampling Manifold (or Stopcock) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111016Safeport Manifold (TM) (or Stopcock)Elcam Medical Acal2011412
+1K033793Cleaner II Rotational Thrombectomy SystemRex Medical200312—
+2K210516Clicky CrossYomura Technologies, Inc.20220—
+2K172266Dynarex Three-Way StopcockDynarex Corporation20180—
+2K123084Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…Elcam Medical Acal20131—
+2K040252Cleaner Rotational Thrombectomy System KitRex Medical200411—
+3K242255Qitexio® 4-Way Stopcock (QIT014)Medex20250—
+3K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P.200610—
+4K120346Cleaner Rotational Thrombectomy SystemRex Medical20128—
+4K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical20109—
+5K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P.20147—
+6K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc.20225—
+6K201705ReVene Thrombectomy CatheterVetex Medical, Ltd.20200—
+7K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™…Argon Medical Devices, Inc.20240—
+7K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™…Argon Medical Devices, Inc.20230—
+7K223891Cobra Catheter SystemEndovascular Engineering20232—
+8K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+9K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—