510(k) Report

Devices descending from K904404

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032274Cook Five Lumen Central Venous CatheterCook, Inc.200433—
+1K024327Setpoint Endovascular Temperature ProbeRadiant Medical20031—
+1K012512Setpoint Endovascular Temperature Management SystemRadiant Medical200227—
+2K081113Cook and Cook Spectrum Central Venous CathetersCook, Inc.200831105
+2K071358Reprieve Endovascular Temperature Therapy SystemRadiant Medical20070—
+2K063405Reprieve Endovascular Temperature Therapy SystemRadiant Medical20071—
+2K060174Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc.200632—
+2K042388Radiant Medical Endocatheter Temperature ProbeRadiant Medical20040—
+2K033623Celsius Control SystemInnercool Therapies, Inc.20042—
+2K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp.2003154
+2K023914Coaxia Flocontrol CatheterCoaxia, Inc.20036—
+2K022366Celsius Control SystemInnercool Therapies200316—
+3K223648Cook® Spectrum® 2 MRC Central Venous CatheterCook Advanced Technologies20231—
+3K182252Cook Unimpregnated Central Venous CatheterCook Incorporated20191—
+3K101326NMI ICNavilyst Medical, Inc.201026—
+3K090970Flocontrol , Model 1028Coaxia, Inc.20091—
+3K080908Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation200811
+3K080700Duoflo CatheterThermopeutix, Inc.20083—
+3K081936Solex Catheter, Model SL2593Alsius Corp.20085—
+3K052443Icy Catheter, Model IC-3893AAlsius Corp.20058—
+3K051912Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…Alsius Corp.20050—
+4K260165Unimpregnated Central Venous CatheterSpectrum Vascular20260—
+4K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV…Spectrum Vascular20240—
+4K192786Gatekeeper Balloon CatheterArch Catheter, LLC20200—
+4K152946TempedySeiratherm GmbH20160—
+4K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+4K121089Nmi Picc IiiNavilyst Medical, Inc.201223—
+4K121990Picc Convenience KitNavilyst Medical, Inc.2012017
+4K112219Tapas CatheterThermopeutix, Inc.20111—
+4K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114—
+4K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation20106—
+4K093847Duflo Catheter (Heparin Coated)Thermopeutix, Inc.20100—
+4K070161Quattro Catheter Model IC4593Alsius Corp.20077—
+5K172885HydroPICCAccess Vascular, Inc.20185—
+5K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.201634
+5K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc.2015421
+5K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc.201506
+5K141175Renovocath RC120Renovorx, Inc.201401
+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—
+6K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20212—
+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—
+7K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20230—
+7K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20221—
+7K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+7K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+7K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+7K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+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—