510(k) Report

Devices descending from K031129

246 later devices reach Poly Per-Q-Cath Picc Catheters; Poly Radpicc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.20232—
+7K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated20220Class I
+7K213203Provena (TM) Midline CatheterC.R. Bard, Inc.202201
+7K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+7K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd20212—
+7K200037Piccolo Medical SmartPICC SystemPiccolo Medical, Inc.20213—
+7K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.20200—
+7K192802primeMidline CathetersPfm Medical, Inc.20190—
+7K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…Interrad Medical, Inc.20191—
+7K180560Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc.20181—
+7K171931Celerity ECG Cable Accessory PackMedcomp (Medical Components, Inc.)20170—
+7K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc.20171—
+7K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+7K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+7K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160Class I
+7K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+7K152261PICC Tip Positioning AidNostix, LLC20155—
+7K143238C3 WaveMedcomp ( Medical Components)20153—
+7K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+7K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc.20141—
+7K132880Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc.20142—
+7K122402LPP (Low Profile Port)Pfm Medical, Inc.20130—
+7K122767Nmi PortNavilyst Medical, Inc.201336
+7K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.20132Class I
+7K073210Modification to: T-Port HP Infusion PortPfm Medical, Inc.20074—
+8K25409525G Huber NeedleMartech Medical Products20260—
+8K260929Neonav ECG Tip Location SystemNavi Medical Technologies20260—
+8K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular20250—
+8K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.20250—
+8K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…Access Vascular, Inc.20250—
+8K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.20250—
+8K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20251—
+8K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.20240—
+8K240486PM2 System and ECGuide ConnectorPiccolo Medical, Inc.20242—
+8K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus…Intera Oncology, Inc.20210—
+8K210629SecurAcathInterrad Medical, Inc.20210—
+8K202672Precision Delivery Infusion SetQuest Medical, Inc.202101
+8K170934C3 Wave SystemMedical Components, Inc (Dba Medcomp_201721
+8K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.)20171—
+8K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.)20164Class I
+8K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+9K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20250—
+9K241587pilot TLSVygon Corporation20250—
+9K220363VPS Rhythm DLX Device with TipTracker TechnologyArrow International, LLC (A subsidiary of Teleflex, Inc.)20220—
+9K180567C3 Wave SystemMedical Components, Inc. (dba MedComp)20180—
+9K17133320G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.)20170—