Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit
FDA 510(k) K040402 · AngioDynamics, Inc.
510(k) numberK040402
Submission
- Device name
- Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit
- Applicant
- AngioDynamics, Inc.
Queensburgy, NY, US - Received
- February 17, 2004
- Decision date
- April 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MSD – Catheter, Hemodialysis, Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code MSD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241581 | Hemodialysis CatheterMSD · Traditional | Haolang Medical USA Corporation | 05/16/2025SESK |
| K210461 | End CapMSD · Traditional | Medical Components Inc (Medcomp) | 09/14/2021SE |
| K203575 | GlidePath Retro Long-Term Hemodialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 07/01/2021SESK |
| K211410 | GlidePath 13F Long-Term Hemodialysis CatheterMSD · Special | Bard Peripheral Vascular, Inc. | 06/04/2021SESK |
| K203767 | Pristine Long-Term Hemodialysis CatheterMSD · Traditional | C B Bard, Inc. | 04/02/2021SESK |
| K202150 | GlidePath 7.5F Long-Term Dialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 11/18/2020SESK |
| K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMSD · Special | Medical Components, Inc. (dba MedComp) | 09/03/2020SE |
| K200627 | GlidePath 10F Long-Term Dialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 06/22/2020SESK |
| K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…MSD · Traditional | C. R. Bard | 03/05/2020SESK |
| K182443 | Pristine Hemodialysis CatheterMSD · Traditional | Pristine Access Technologies , Ltd. | 05/31/2019SE |
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| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…OAB · Traditional | 12/06/2024SE |
| K240397 | AlphaVac MMA F1885 System (H787253020)QEZ · Traditional | 04/01/2024SE |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsGEX · Special | 07/20/2023SE |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/27/2023SE |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 03/07/2023SE |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemQEZ · Traditional | 04/04/2022SE |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and AccessoriesNEY · Special | 12/03/2021SE |
Questions and answers
When was Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit cleared by the FDA?
Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit (K040402) received a 510(k) decision of Substantially Equivalent on April 19, 2004, 62 days after the submission was received.
What is the product code of K040402?
The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.