Product code EZC
- Device name
- Catheter, Coude
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222279 | Rusch Intermittent Urethral Catheters | Teleflex Medical | 2022-08-29 |
| K173596 | Rusch Intermittent Urethral Catheters | Teleflex Medical | 2018-01-29 |
| K946282 | UNIVERSAL URETHRAL CATHETER | Louisville Laboratories, Inc. | 1995-03-31 |
| K913341 | BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER | C.R. Bard, Inc. | 1992-01-27 |
| K910846 | BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF | C.R. Bard, Inc. | 1991-08-16 |
| K910195 | BARD HYDROGEL-COATED FOLEY CATHETERS | C.R. Bard, Inc. | 1991-08-09 |
| K910197 | HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS | C.R. Bard, Inc. | 1991-08-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 14026704942517 | RUSCH | TELEFLEX INCORPORATED | 2026-05-15 |
| 14026704942500 | RUSCH | TELEFLEX INCORPORATED | 2026-05-15 |
| 14026704942456 | RUSCH | TELEFLEX INCORPORATED | 2026-05-15 |
| 14026704942463 | RUSCH | TELEFLEX INCORPORATED | 2026-05-15 |
| 14026704942470 | RUSCH | TELEFLEX INCORPORATED | 2026-05-15 |
| 14026704942487 | RUSCH | TELEFLEX INCORPORATED | 2026-05-15 |
| 14026704942494 | RUSCH | TELEFLEX INCORPORATED | 2026-05-15 |
| 10854913006195 | Urinary Catheter, 16 Fr | UROGEN PHARMA LTD | 2025-11-17 |
| 10854913006157 | Urinary Catheter, 16 Fr | UROGEN PHARMA LTD | 2025-11-16 |
| 10854913006119 | Urinary Catheter | UROGEN PHARMA LTD | 2022-06-01 |
| 10854913006126 | Urinary Catheter | UROGEN PHARMA LTD | 2022-06-01 |
| 10852141007731 | COMPACTCATH - Lite | COMPACTCATH, INC. | 2019-09-01 |
| 00801741017759 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-08-06 |
| 00801741017742 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-08-06 |
| 00801741017735 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-08-06 |
| 00801741000287 | Bard® Foley Tray with Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-06-13 |
| 00801741017810 | Bardex® Lubricath® Foley Catheter Coude Tip | C. R. Bard, Inc. | 2016-06-10 |
| 00801741017803 | Bardex® Lubricath® Foley Catheter Coude Tip | C. R. Bard, Inc. | 2016-06-10 |
| 00801741017674 | Bardex® Lubricath® Pediatric Foley Catheter | C. R. Bard, Inc. | 2016-06-10 |
| 00801741017667 | Bardex® Lubricath® Pediatric Foley Catheter | C. R. Bard, Inc. | 2016-06-10 |
| 00801741017537 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-03-19 |
| 00801741017544 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-03-19 |
| 00801741017551 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-03-19 |
| 00801741017520 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-03-19 |
| 00801741017513 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-03-19 |
| 00801741017506 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-03-19 |
| 00801741017490 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-03-19 |
| 00801741017483 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-03-19 |
| 00801741017476 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-03-19 |
| 00801741017469 | Bardex® Lubricath® Foley Catheter | C. R. Bard, Inc. | 2016-03-19 |