Bard (R) Lubricious - Coated Ureteral Stent Suture
FDA 510(k) K903345 · C.R. Bard, Inc.
510(k) numberK903345
Submission
- Device name
- Bard (R) Lubricious - Coated Ureteral Stent Suture
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- July 25, 1990
- Decision date
- April 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FAD – Stent, Ureteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4620
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code FAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251890 | Disposable Ureteral StentsFAD · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 02/20/2026SE |
| K251469 | Endura Ureteral Stent and Stent SetFAD · Traditional | Cathegenix (Xiamen) Co., Ltd. | 12/19/2025SESK |
| K243039 | Ureteral Stents (AF-D series)FAD · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 06/18/2025SE |
| K243830 | Disposable ureteral stentFAD · Traditional | Shenzhen Trious Medical Technology Co., Ltd. | 05/14/2025SE |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive…FAD · Special | Boston Scientific Corporation | 04/15/2025SE |
| K232920 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional | Ureteral Stent Company | 03/22/2024SE |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL…FAD · Traditional | Boston Scientific Corporation | 11/10/2022SESK |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…FAD · Traditional | Coloplast Corp. | 06/08/2022SESK |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…FAD · Traditional | Ureteral Stent Company | 03/17/2022SE |
| K213186 | NovoFlow Reinforced Ureteral StentFAD · Traditional | Coloplast Corp. | 02/16/2022SESK |
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| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | 05/29/2026SESK |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251864 | Rubber Utility CatheterKOD · Traditional | 02/23/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was Bard (R) Lubricious - Coated Ureteral Stent Suture cleared by the FDA?
Bard (R) Lubricious - Coated Ureteral Stent Suture (K903345) received a 510(k) decision of Substantially Equivalent on April 30, 1991, 279 days after the submission was received.
What is the product code of K903345?
The FDA product code is FAD – Stent, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4620.