Bard Dual Lumen Ureteral Catheter
FDA 510(k) K032521 · C.R. Bard, Inc.
510(k) numberK032521
Submission
- Device name
- Bard Dual Lumen Ureteral Catheter
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- August 15, 2003
- Decision date
- November 14, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EYB – Catheter, Ureteral, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192183 | RocaTub Ureteral CatheterEYB · Traditional | Promepal Sam | 04/23/2020SE |
| K191187 | Dornier MINNOW Ureteral CatheterEYB · Traditional | Dornier Medtech America, Inc. | 09/18/2019SE |
| K183323 | UPJ Occlusion Balloon CatheterEYB · Traditional | Cook Incorporated | 08/05/2019SESK |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterEYB · Traditional | Cook Incorporated | 06/17/2019SESK |
| K182122 | Ureteric CathetersEYB · Traditional | Coloplast Corp. | 10/04/2018SE |
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterEYB · Traditional | Cook Incorporated | 09/14/2018SE |
| K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersEYB · Traditional | Coloplast Corp. | 12/21/2017SE |
| K133750 | Occluder Occlusion Balloon CatheterEYB · Traditional | Boston Scientific Corporation | 01/08/2014SE |
| K092250 | Medline Red Rubber Urethral CatheterEYB · Traditional | Medline Industries, Inc. | 01/21/2010SE |
| K083788 | Endo Optiks Urological Catheter for Endoscopy, Model SessrEYB · Traditional | Endooptiks, Inc. | 03/03/2009SE |
More from Endooptiks, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | 07/10/2026SE |
| 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 Dual Lumen Ureteral Catheter cleared by the FDA?
Bard Dual Lumen Ureteral Catheter (K032521) received a 510(k) decision of Substantially Equivalent on November 14, 2003, 91 days after the submission was received.
What is the product code of K032521?
The FDA product code is EYB – Catheter, Ureteral, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5130.