510(k) K180530
- Device
- Imager II Urology Torque Catheter
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K180530
- Product code
- KOD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-10
- Date received
- 2018-02-28
- Regulation
- 876.5130
- Classification name
- Catheter, Urological
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- 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#
- 3015173212
- 3014404707
- 1423537
- 3007134520
- 3003898360
- 3011987967
- 3013024191
- 3014656749
- 3007289408
- 3010400865
- 8022978
- 2431166
- 9680787
- 1833700
- 1000121056
- 2025851
- 9617604
- 2032112
- 3018094310
- 2011171
- 3004784537
- 3015895045
- 1048735
- 1018233
- 1054241
- 3009171251
- 1928237
- 1721686
- 8043792
- 1313046
- 1220477
- 3010220595
- 2029015
- 3010273872
- 1921846
- 3005483737
- 3003903031
- 2124215
- 3008307705
- 9611590
- 1055236
- 3004111573
- 9617592
- 1825146
- 3008816891
- 3008191244
- 3015453963
- 3008806809
- 9611712
- 9610849
- 3009337401
- 1820334
- 3007829657
- 9612030
- 3014195785
- 2936999
- 3005012805
- 3009504230
- 3004365956
- 9681384
- 1828132
- 3013530345
- 3030733800
- 2320762
- 1043214
- 3006174295
- 3007007790
- 9681834
- 3005674464
- 9616683
- 3022518300
- 3005099803
- 3006430057
- 1000317571
- 1417592
- 3004727093
- 3017171849
- 1000393132
- 3013517171
- 8040607
Source Documents#
Other 510(k) Records For Product Code KOD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251864 | Rubber Utility Catheter | C.R. Bard, Inc. | 2026-02-23 |
| K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | 2022-12-16 |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | Allwin Medical Devices, Inc. | 2022-10-13 |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma, Ltd. | 2021-11-19 |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | 2019-05-24 |
| K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | 2018-10-30 |
| K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | 2018-06-28 |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Cook Incorporated | 2018-03-07 |
| K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated | 2018-02-16 |
| K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter | Cook Incorporated | 2018-02-01 |
| K172924 | GentleCath Intermittent Urinary Catheter | Convatec Limited | 2017-11-21 |
| K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | 2016-09-20 |
| K160877 | United Urologics Closed System Catheter | Robling Medical, Inc. | 2016-05-20 |
| K140953 | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER | Convatec, Ltd. | 2014-08-01 |
| K110491 | BACKSTOP CATHETER | Pluromed, Inc. | 2011-03-16 |
Legacy Summary#
summary
FDA Review#
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