510(k) Report

Devices descending from K994374

18 later devices reach Soaker Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191470C-CAT Anaesthesia Catheter kitCimpax Aps20190—
+1K060119Mckinley Saturation CatheterMckinley Medical, LLC20060—
+1K043456Modification to Soaker CatheterI-Flow Corp.200511—
+1K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc.20041—
+1K024190Fenestrated Infusion CatheterPromedic, Inc.20030—
+1K022869Soaker CatheterI-Flow Corp.200212—
+2K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation20144—
+2K080675Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie20082—
+2K061356Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion…Advanced Infusion, Inc.20060—
+2K060933Solace Post-Operative Pain Relief Infusion SystemApex Medical Technologies, Inc.20060—
+2K051401ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterI-Flow Corp.20054—
+3K171193Certa CatheterFerrosan Medical Devices Sp. Z.O.O.20170—
+3K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitHalyard Health20160—
+3K152952E-CathPAJUNK GmbH Medizintechnologie20161—
+3K111031Painfusor CatheterPlan 1 Health, S.R.L.20111—
+3K072702Stryker Antimic CatheterStryker Instruments, Instruments Div.20080—
+4K202699E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie20200—
+4K193664SubQKath Catheter and Needle SetHk Surgical20200—