Bardex I.C. Pediatric Foley Catheter
FDA 510(k) K993464 · C.R. Bard, Inc.
510(k) numberK993464
Submission
- Device name
- Bardex I.C. Pediatric Foley Catheter
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- October 13, 1999
- Decision date
- December 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJC – Catheter, Urological (Antimicrobial) And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code MJC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233094 | Wellead® Latex Foley CatheterMJC · Traditional | Well Lead Medical (Hainan) Co., Ltd. | 06/06/2024SE |
| K040658 | Bardex I.C. Latex Foley CatheterMJC · Traditional | C.R. Bard, Inc. | 09/29/2004SE |
| K033477 | Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitMJC · Traditional | Rochester Medical Corp. | 06/10/2004SE |
| K000251 | Spectrum Silicone Foley CatheterMJC · Traditional | Cook Urological, Inc. | 08/30/2000SE |
| K001143 | Release NF Antibacterial Foley Catheter, Antibacterial Personal CatheterMJC · Traditional | Rochester Medical Corp. | 07/07/2000SE |
| K984136 | Bardex Lubri-Sil I.C. Foley CatheterMJC · Traditional | Bard Medical Div. | 02/16/1999SE |
| K983101 | Bardex I.C 4-WAY Foley Catheter Model 1865SIXX XX = 18,20,22,24MJC · Abbreviated | C.R. Bard, Inc. | 11/03/1998SE |
| K971627 | Silicone Antibacterial Foley CatheterMJC · Traditional | Rochester Medical Corp. | 01/13/1998SE |
| K910318 | Bard(R) Hydrogel/Silver-Coated Foley CatheterMJC · Traditional | C.R. Bard, Inc. | 08/18/1994SE |
More from C.R. Bard, 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 Bardex I.C. Pediatric Foley Catheter cleared by the FDA?
Bardex I.C. Pediatric Foley Catheter (K993464) received a 510(k) decision of Substantially Equivalent on December 10, 1999, 58 days after the submission was received.
What is the product code of K993464?
The FDA product code is MJC – Catheter, Urological (Antimicrobial) And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.5130.