510(k) Report

Devices descending from K900263

33 later devices reach Antimicrobial Multi-Lumen Central Venous Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073520Angiotech CVCAngiotech Pharmaceuticals, Inc.20080—
+1K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc.200702
+1K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc.200714Class I
+1K021130Specath Central Venous Catheter KitsSpecial Medical Co., Ltd.20032—
+1K012193Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc.20022—
+1K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue…Arrow Intl., Inc.20008Class I
+1K961392Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IISil-Med Corp.19973—
+1K961194Antimicrobial Mediastinal Silicone DrainSil-Med Corp.19960—
+2K190855BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd)20193—
+2K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC20161—
+2K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.)20150Class I
+2K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+2K122091Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute…Cook, Inc.20131—
+2K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.)20124—
+2K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC20092—
+2K070451Able Central Venous CatheterFoshan Nanhai Bai HE Medical Technology Co., Ltd.20071—
+2K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc.20060—
+2K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc.20061—
+2K022688Versabond AB Bone CementSmith & Nephew, Inc.200401
+2K022676Orthoguard AB Antimicrobial SleeveSmith & Nephew, Inc.20020—
+2K011761Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral…Arrow Intl., Inc.20011Class I
+3K242429CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SystemBecton Dickinson Inc. (Bd)20250—
+3K221827Mais Central Venous CatheterSaudi Mais Co. For Medical Products20230—
+3K193158ACENT™ Central Venous CatheterGlobal Medikit Limited20200—
+3K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)Bard Access Systems, Inc. (Bard Has Joined Bd)20200—
+3K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…Edwards Lifescience, LLC201801
+3K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated20170—
+3K160747Angel CatheterBio2 Medical, Inc.20160—
+3K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+3K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC20120—
+3K032962AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial SurfaceArrow Intl., Inc.20030—
+4K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+5K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—