510(k) Report

Devices descending from K981329

24 later devices reach Feth-R-Kath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133316Spirol Block (19 GA. Open End Models), (20 GA. Open End Models), (19 GA. Closed End…Epimed International, Inc.20140—
+1K050557Amt NanocathAmerican Medical Technologies, Inc.20050—
+1K994374Soaker CatheterI-Flow Corp.200018—
+1K991879Spring-Wound Epidural CatheterMicor, Inc.19994—
+2K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc.20230—
+2K191470C-CAT Anaesthesia Catheter kitCimpax Aps20190—
+2K060119Mckinley Saturation CatheterMckinley Medical, LLC20060—
+2K043456Modification to Soaker CatheterI-Flow Corp.200511—
+2K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc.20041—
+2K031600Conduction CatheterMicor, Inc.20031—
+2K024190Fenestrated Infusion CatheterPromedic, Inc.20030—
+2K022869Soaker CatheterI-Flow Corp.200212—
+3K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation20144—
+3K080675Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie20082—
+3K061356Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion…Advanced Infusion, Inc.20060—
+3K060933Solace Post-Operative Pain Relief Infusion SystemApex Medical Technologies, Inc.20060—
+3K051401ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterI-Flow Corp.20054—
+4K171193Certa CatheterFerrosan Medical Devices Sp. Z.O.O.20170—
+4K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitHalyard Health20160—
+4K152952E-CathPAJUNK GmbH Medizintechnologie20161—
+4K111031Painfusor CatheterPlan 1 Health, S.R.L.20111—
+4K072702Stryker Antimic CatheterStryker Instruments, Instruments Div.20080—
+5K202699E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie20200—
+5K193664SubQKath Catheter and Needle SetHk Surgical20200—