510(k) Report

Devices descending from K962577

59 later devices reach Arrowgard Blue Quad-Lumen Central Venous Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160747Angel CatheterBio2 Medical, Inc.20160—
+1K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc.200714Class I
+1K060174Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc.200632—
+1K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp.2003116
+2K190855BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd)20193—
+2K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC20161—
+2K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.201634
+2K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc.2015421
+2K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+2K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.)20124—
+2K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation20106—
+2K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC20092—
+2K081113Cook and Cook Spectrum Central Venous CathetersCook, Inc.200831105
+2K051912Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…Alsius Corp.20050—
+2K033623Celsius Control SystemInnercool Therapies, Inc.20042—
+3K242429CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SystemBecton Dickinson Inc. (Bd)20250—
+3K221827Mais Central Venous CatheterSaudi Mais Co. For Medical Products20230—
+3K223648Cook® Spectrum® 2 MRC Central Venous CatheterCook Advanced Technologies20231—
+3K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20212—
+3K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)Bard Access Systems, Inc. (Bard Has Joined Bd)20200—
+3K182252Cook Unimpregnated Central Venous CatheterCook Incorporated20191—
+3K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…Edwards Lifescience, LLC201801
+3K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+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—
+3K101326NMI ICNavilyst Medical, Inc.201026—
+3K080908Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation200811
+4K260165Unimpregnated Central Venous CatheterSpectrum Vascular20260—
+4K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV…Spectrum Vascular20240—
+4K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20230—
+4K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20221—
+4K152946TempedySeiratherm GmbH20160—
+4K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+4K121089Nmi Picc IiiNavilyst Medical, Inc.201223—
+4K121990Picc Convenience KitNavilyst Medical, Inc.2012017
+4K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114—
+5K172885HydroPICCAccess Vascular, Inc.20185—
+5K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+5K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc.201506
+5K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+5K131694Nmi Port II CatheterNavilyst Medical, Inc.201322
+5K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc.20137—
+5K131038Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc.2013312
+5K122882Nmi Hpicc IiiNavilyst Medical, Inc.201212—
+6K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.20200—
+6K193015HydroPICC (PICC-142)Access Vascular, Inc.202044
+6K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+6K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+6K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+6K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+6K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+7K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+7K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…Access Vascular, Inc.20250—
+7K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+7K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+7K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+7K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+8K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular20250—
+8K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…Access Vascular, Inc.20250—