510(k) Report

Devices descending from K051991

119 later devices reach Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…Access Vascular, Inc.20250—
+5K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated20220Class I
+5K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+5K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…Vygon USA201801
+5K173114primeMidline CathetersPfm Medical, Inc.20181—
+5K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+5K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+5K162900PowerMidline CatheterC.R. Bard, Inc.201613
+5K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+5K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+5K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+5K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+5K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.20132Class I
+6K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular20250—
+6K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…Access Vascular, Inc.20250—
+6K213203Provena (TM) Midline CatheterC.R. Bard, Inc.202201
+6K192802primeMidline CathetersPfm Medical, Inc.20190—
+6K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+6K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160Class I