510(k) K172929
- Device
- Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, And Clear Renal Sheath
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K172929
- Product code
- LJE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-01-10
- Date received
- 2017-09-25
- Regulation
- 510(k) Premarket Notification
- Classification name
- Catheter, Nephrostomy
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Gastroenterology/Urology
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Daniel FitzDaniel
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers#
- 3010155661
- 3023460764
- 3019946783
- 3043337628
- 2183744
- 3007146453
- 3007695959
- 1828132
- 9610711
- 3030733800
- 3005580113
- 3012480535
- 3004730544
- 3010273872
- 3003790304
- 2124215
- 3005099803
- 3002807314
- 3030446844
- 3027260597
- 3017425975
- 3035451914
- 1625425
- 3010419931
- 3004111573
- 3005987240
- 1000121056
- 1825146
- 1644312
- 3011050570
- 1000393132
- 3033848208
- 2030624
- 3005941719
- 3003814961
- 1646831
- 1225798
- 1820334
- 1647149
- 3006082230
- 3007156625
- 3012494290
- 2126666
- 1018233
- 9681477
- 3013557562
- 3012649202
- 1450395
- 9681260
- 3004859241
- 3030087693
- 1225687
Source Documents#
Other 510(k) Records For Product Code LJE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250448 | Disposable Percutaneous Nephrostomy Dilatation Kit | Shenzhen Trious Medical Technology Co., Ltd. | 2025-07-03 |
| K222705 | Introducer Needle | Youcare Technology Co.,Ltd. (Wuhan) | 2023-05-22 |
| K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets | Coloplast Corp. | 2022-03-10 |
| K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | Coloplast Corp. | 2020-12-17 |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc | Cook Incorporated | 2020-01-29 |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture Set | Cook Incorporated | 2019-12-16 |
| K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set | Cook Incorporated | 2019-07-16 |
| K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | Cook Incorporated | 2019-05-17 |
| K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | Cook Incorporated | 2019-03-27 |
| K181713 | Ultraxx Nephrostomy Balloon Catheter Set | Cook Incorporated | 2018-08-17 |
| K171601 | Ultraxx Nephrostomy Balloon Catheter | Cook Incorporated | 2018-02-23 |
| K172527 | 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 | Cook Incorporated | 2017-10-19 |
| K160077 | RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set | Jbw7 Innovations, LLC | 2016-07-12 |
| K132383 | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER | Gyrus Acmi, Inc. | 2014-02-04 |
| K121614 | NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER | Boston Scientific Corp | 2012-09-18 |
Legacy Summary#
summary
FDA Review#
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