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FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K183066	The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model	DYB	2019-07-25	View
510(k)	K181563	The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology	DQY	2018-09-26	View
510(k)	K182243	The CVC WAND Safety Introducer with Valved Peelable Sheath	DYB	2018-09-18	View
510(k)	K162322	the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model	DYB	2016-11-17	View
510(k)	K131148	THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH	DYB	2013-09-04	View
510(k)	K131300	THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER	DYB	2013-06-07	View

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