510(k) Report

Devices descending from K033843

33 later devices reach Spectrum Central Venous Catheter with or Without Hydrophilic Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081113Cook and Cook Spectrum Central Venous CathetersCook, Inc.200831105
+1K060174Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc.200632—
+2K223648Cook® Spectrum® 2 MRC Central Venous CatheterCook Advanced Technologies20231—
+2K182252Cook Unimpregnated Central Venous CatheterCook Incorporated20191—
+2K101326NMI ICNavilyst Medical, Inc.201026—
+3K260165Unimpregnated Central Venous CatheterSpectrum Vascular20260—
+3K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV…Spectrum Vascular20240—
+3K121089Nmi Picc IiiNavilyst Medical, Inc.201223—
+3K121990Picc Convenience KitNavilyst Medical, Inc.2012017
+3K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114—
+4K172885HydroPICCAccess Vascular, Inc.20185—
+4K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc.201506
+4K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+4K131694Nmi Port II CatheterNavilyst Medical, Inc.201322
+4K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc.20137—
+4K131038Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc.2013312
+4K122882Nmi Hpicc IiiNavilyst Medical, Inc.201212—
+5K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.20200—
+5K193015HydroPICC (PICC-142)Access Vascular, Inc.202044
+5K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+5K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+5K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+5K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+5K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+6K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+6K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…Access Vascular, Inc.20250—
+6K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+6K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+6K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+6K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+6K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+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—