510(k) Report

Devices descending from K022895

29 later devices reach Elcam Stopcocks and Manifolds through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal…Monumedical, LLC20190—
+1K141254Elcam Stopcocks and ManifoldsElcam Medical Acal201411
+1K053405BacstopElcam Medical Acal20062—
+1K060231Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-StopcockElcam Medical Acal2006420
+1K032393Induction and Sampling Manifold (or Stopcock)Elcam Medical Acal2003182
+2K223499Three Way Stop CockM/S Romsons International20230—
+2K211204SafePort (TM) Manifold (or Stopcock)Elcam Medical Acal20220—
+2K111016Safeport Manifold (TM) (or Stopcock)Elcam Medical Acal2011412
+2K103165Blood Sampling SetAcacia, Inc.20100—
+2K082106Elcam Antimicrobial Closed Stopcocks (DSS and TSS)Elcam Medical Acal20080—
+2K073396Antimicrobial Ultrasite Value, Ultrasite AGB.Braun Medical, Inc.20080—
+2K071400Smartsite StopcockCardinal Health, Alaris Products20070—
+2K033793Cleaner II Rotational Thrombectomy SystemRex Medical200312—
+3K210516Clicky CrossYomura Technologies, Inc.20220—
+3K172266Dynarex Three-Way StopcockDynarex Corporation20180—
+3K123084Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…Elcam Medical Acal20131—
+3K040252Cleaner Rotational Thrombectomy System KitRex Medical200411—
+4K242255Qitexio® 4-Way Stopcock (QIT014)Medex20250—
+4K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P.200610—
+5K120346Cleaner Rotational Thrombectomy SystemRex Medical20128—
+5K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical20109—
+6K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P.20147—
+7K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc.20225—
+7K201705ReVene Thrombectomy CatheterVetex Medical, Ltd.20200—
+8K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™…Argon Medical Devices, Inc.20240—
+8K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™…Argon Medical Devices, Inc.20230—
+8K223891Cobra Catheter SystemEndovascular Engineering20232—
+9K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+10K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—