510(k) Report

Devices descending from K051417

126 later devices reach 6 FR FL Powerhohn and Powerline Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K162900PowerMidline CatheterC.R. Bard, Inc.201613
+5K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…Arrow International, Inc. (Subsidiary of Teleflex, Inc.)201612
+5K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+5K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.20160—
+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—
+5K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex20133—
+5K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20122Class I
+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—
+6K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated20220Class I
+6K213203Provena (TM) Midline CatheterC.R. Bard, Inc.202201
+6K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+6K192802primeMidline CathetersPfm Medical, Inc.20190—
+6K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+6K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+6K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+6K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+6K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+6K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.20132Class I
+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—
+7K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160Class I