FDA 510(k) Applications Submitted by Coloplast Corp

FDA 510(k) Number	Submission Date	Device Name	Applicant
K211911	06/21/2021	Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets	Coloplast Corp
K180057	01/08/2018	VORTEK URETERAL DOUBLE LOOP STENT	Coloplast Corp
K170362	02/06/2017	VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS	Coloplast Corp
K170422	02/13/2017	BIOSOFT DUO DOUBLE LOOP URETERAL STENTS	Coloplast Corp
K180469	02/21/2018	ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent	Coloplast Corp
K170531	02/22/2017	Ureteral Dilators and Percutaneous Nephrostomy Dilators	Coloplast Corp
K171043	04/07/2017	Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters	Coloplast Corp
K201007	04/17/2020	In-Ka Ureteral Balloon Dilatation Catheter	Coloplast Corp
K201165	05/01/2020	In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath	Coloplast Corp
K201436	06/01/2020	Vortek Single Loop Ureteral Stent	Coloplast Corp
K182122	08/06/2018	Ureteric Catheters	Coloplast Corp
K182831	10/09/2018	SabreLine and SabreGuard Laser Fibers	Coloplast Corp
K213185	09/29/2021	ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits	Coloplast Corp
K213186	09/29/2021	NovoFlow Reinforced Ureteral Stent	Coloplast Corp