510(k) Report

Devices descending from K813186

46 later devices reach Perfix Set for Epidural Anesthesia W/Tuo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060311Epilong Kit for AnesthesiologyPAJUNK GmbH Medizintechnologie20065—
+1K060563Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH20061—
+1K030830B. Braun Nerve Block CatheterB.Braun Medical, Inc.200310—
+1K013610Perifix Safety Epidural NeedlesB.Braun Medical, Inc.20025—
+1K994374Soaker CatheterI-Flow Corp.200018—
+1K994275Sims Portex Anesthesia CatheterSims Portex, Inc.20001—
+1K991543Intraop CatheterI-Flow Corp.199931—
+1K971233Soft Tip Epidural Catheter KitB.Braun Medical, Inc.199712—
+1K962696Perifix Pediatric Epidural KitB.Braun Medical, Inc.199731
+2K191470C-CAT Anaesthesia Catheter kitCimpax Aps20190—
+2K121525Perifuse CatheterSmiths Medical Asd, Inc.20120—
+2K082183Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie20080—
+2K081404Spinal Integration Spinal-Eze Intraoperative Epidural Catheter KitSpinal Integration, LLC20080—
+2K062902Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie20071—
+2K062900Pajunks Stimulong Tsui-Method SetPAJUNK GmbH Medizintechnologie20072—
+2K060119Mckinley Saturation CatheterMckinley Medical, LLC20060—
+2K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…Innospine, Inc.200531
+2K043456Modification to Soaker CatheterI-Flow Corp.200511—
+2K042488Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc.20049—
+2K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc.20041—
+2K041158Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing SystemAtrion Medical Products, Inc.20040—
+2K032981Sppro Esp, Models Esp 603-18-05, Esp 603-18-09Invamed Technologies, Inc.20040—
+2K033080Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc.20042—
+2K024190Fenestrated Infusion CatheterPromedic, Inc.20030—
+2K022869Soaker CatheterI-Flow Corp.200212—
+3K153297Perifix and Contiplex CatheterB.Braun Medical, Inc.20160—
+3K150731Medline Epidural CatheterMedline Industries, Inc.20160—
+3K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation20144—
+3K102594IO-Flex CatheterBaxano, Inc.20110—
+3K090884Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc.20090—
+3K082164Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus…PAJUNK GmbH Medizintechnologie20080—
+3K080675Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie20082—
+3K073516Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…Kyphon, Inc.20080—
+3K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc.20071—
+3K061356Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion…Advanced Infusion, Inc.20060—
+3K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…Kyphon, Inc.20062—
+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—
+3K050557Amt NanocathAmerican Medical Technologies, Inc.20050—
+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—