510(k) Report

Devices descending from K061179

47 later devices reach Powerhickman Long-Term Intravascular Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110627Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd.20115—
+1K101326NMI ICNavilyst Medical, Inc.201026—
+1K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc.200714Class I
+2K190855BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd)20193—
+2K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC20161—
+2K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+2K121933Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis…Marvao Medical Devices, Ltd.20134—
+2K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.)20124—
+2K121089Nmi Picc IiiNavilyst Medical, Inc.201223—
+2K121990Picc Convenience KitNavilyst Medical, Inc.2012017
+2K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114—
+2K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC20092—
+3K242429CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SystemBecton Dickinson Inc. (Bd)20250—
+3K221827Mais Central Venous CatheterSaudi Mais Co. For Medical Products20230—
+3K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)Bard Access Systems, Inc. (Bard Has Joined Bd)20200—
+3K172885HydroPICCAccess Vascular, Inc.20185—
+3K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…Edwards Lifescience, LLC201801
+3K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Marvao Medical Devices, Ltd.20161—
+3K160747Angel CatheterBio2 Medical, Inc.20160—
+3K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc.201506
+3K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.20142—
+3K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+3K133796Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis…Marvao Medical Devices, Ltd.20143—
+3K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+3K131694Nmi Port II CatheterNavilyst Medical, Inc.201322
+3K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc.20137—
+3K131038Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc.2013312
+3K122882Nmi Hpicc IiiNavilyst Medical, Inc.201212—
+3K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC20120—
+4K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.20200—
+4K193015HydroPICC (PICC-142)Access Vascular, Inc.202044
+4K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+4K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+4K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+4K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+4K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+4K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+4K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+5K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+5K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…Access Vascular, Inc.20250—
+5K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+5K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+5K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+5K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+5K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+6K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular20250—
+6K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…Access Vascular, Inc.20250—