510(k) Report

Devices descending from K043502

133 later devices reach 6 FR Poly Per-Q-Cath Triple Lumen Picc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+5K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+5K133796Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis…Marvao Medical Devices, Ltd.20143—
+5K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+5K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+5K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+5K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex20133—
+5K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20122Class I
+5K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+5K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC20120—
+6K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+6K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+6K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…Access Vascular, Inc.20250—
+6K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated20220Class I
+6K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+6K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…Interrad Medical, Inc.20191—
+6K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…Vygon USA201801
+6K173114primeMidline CathetersPfm Medical, Inc.20181—
+6K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+6K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+6K162900PowerMidline CatheterC.R. Bard, Inc.201613
+6K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+6K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+6K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+6K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+6K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.20132Class I
+7K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular20250—
+7K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…Access Vascular, Inc.20250—
+7K213203Provena (TM) Midline CatheterC.R. Bard, Inc.202201
+7K210629SecurAcathInterrad Medical, Inc.20210—
+7K192802primeMidline CathetersPfm Medical, Inc.20190—
+7K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+7K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160Class I