510(k) Report

Devices descending from K083763

37 later devices reach Zeus CT Picc 4 FR and 5 FR Single and Dual Lumen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113225Nylus PiccSemprus Biosciences20120—
+1K121089Nmi Picc IiiNavilyst Medical, Inc.201223—
+1K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.)201212Class I
+2K172885HydroPICCAccess Vascular, Inc.20185—
+2K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…Arrow International, Inc. (Subsidiary of Teleflex, Inc.)201612
+2K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+2K131694Nmi Port II CatheterNavilyst Medical, Inc.201322
+2K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc.20137—
+2K131038Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc.2013312
+2K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex20133—
+2K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.)20124—
+2K122882Nmi Hpicc IiiNavilyst Medical, Inc.201212—
+2K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20122Class I
+3K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated20220Class I
+3K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.20200—
+3K193015HydroPICC (PICC-142)Access Vascular, Inc.202044
+3K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+3K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+3K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+3K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+3K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+3K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+3K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+3K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.20132Class I
+4K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+4K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…Access Vascular, Inc.20250—
+4K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+4K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+4K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+4K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160Class I
+4K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+4K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+4K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+5K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular20250—
+5K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…Access Vascular, Inc.20250—
+5K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+5K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc.201506