FDA 510(k) Applications for Medical Device Product Code "LJE"
(Catheter, Nephrostomy)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K121614 | BOSTON SCIENTIFIC CORP. | NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER | 09/18/2012 |
| K172929 | Boston Scientific Corporation | Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath | 01/10/2018 |
| K063632 | C.R. BARD, INC. | X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER | 01/05/2007 |
| K080944 | C.R. BARD, INC. | X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER | 10/23/2008 |
| K051316 | C.R. BARD, INC. | X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER | 07/18/2005 |
| K201165 | Coloplast Corp | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | 12/17/2020 |
| K211911 | Coloplast Corp | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets | 03/10/2022 |
| K172527 | Cook Incorporated | Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe | 10/19/2017 |
| K191498 | Cook Incorporated | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | 01/29/2020 |
| K183051 | Cook Incorporated | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set | 07/16/2019 |
| K190903 | Cook Incorporated | Lawson Retrograde Nephrostomy Wire Puncture Set | 12/16/2019 |
| K183035 | Cook Incorporated | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | 05/17/2019 |
| K181735 | Cook Incorporated | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | 03/27/2019 |
| K171601 | Cook Incorporated | Ultraxx Nephrostomy Balloon Catheter | 02/23/2018 |
| K181713 | Cook Incorporated | Ultraxx Nephrostomy Balloon Catheter Set | 08/17/2018 |
| K961933 | COOK UROLOGICAL, INC. | CIRCLE NEPHROSTOMY CATHETER SET | 07/18/1996 |
| K024050 | COOK UROLOGICAL, INC. | COOK NEPHROSTOMY DILATION BALLOON CATHETER SET | 02/27/2003 |
| K132383 | GYRUS ACMI, INC. | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER | 02/04/2014 |
| K160077 | JBW7 Innovations, LLC | RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set | 07/12/2016 |
| K953713 | MANAN MEDICAL PRODUCTS, INC. | MANAN GENERAL UTILITY DRAINAGE CATHETER | 03/26/1996 |
| K953601 | MANAN MEDICAL PRODUCTS, INC. | MANAN UNIVERSAL SUMP DRAINAGE CATHETER | 03/26/1996 |
| K980193 | MEDICAL DEVICE TECHNOLOGIES, INC. | MANAN GENERAL UTILITY DRAINAGE CATHETER | 05/27/1998 |
| K980192 | MEDICAL DEVICE TECHNOLOGIES, INC. | MANAN NEPHROSTOMY DRAINAGE CATHETER | 05/27/1998 |
| K011121 | RUSCH INTL. | RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS | 11/16/2001 |
| K980889 | URESIL CORP. | URESIL NEPHRO-URETERAL STENT | 04/08/1998 |
| K981344 | URESIL CORP. | URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING | 09/10/1998 |
| K222705 | YouCare Technology Co., Ltd. (Wuhan) | Introducer Needle | 05/22/2023 |
| K990689 | ZCV ,INC. | ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 | 09/03/1999 |
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