Cascade Hemodialysis/Apheresis Catheter
FDA 510(k) K130851 · Health Line International Corporation
510(k) numberK130851
Submission
- Device name
- Cascade Hemodialysis/Apheresis Catheter
- Applicant
- Health Line International Corporation
Centerville, UT, US - Received
- March 27, 2013
- Decision date
- January 9, 2014
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
More from Pristine Access Technologies , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | 06/22/2026SE |
| K222170 | Power Acute Triple Lumen Hemodialysis CatheterNIE · Traditional | 01/13/2023SE |
| K200426 | Acute Dual Lumen Hemodialysis CatheterMPB · Traditional | 12/24/2020SESK |
| K200263 | Health Line CT Midline CatheterFOZ · Special | 03/12/2020SE |
| K192533 | Health Line CT CVCFOZ · Traditional | 12/10/2019SE |
| K160448 | ArtlineDQY · Traditional | 07/12/2016SE |
| K140270 | Nexus Midline CT CatheterFOZ · Traditional | 08/20/2014SE |
| K130034 | Uni-PiccLJS · Traditional | 03/08/2013SE |
| K120548 | Hlic Needle-Less ValveFPA · Traditional | 05/04/2012SE |
| K101329 | Synergy CT PiccLJS · Traditional | 08/19/2010SE |
Questions and answers
When was Cascade Hemodialysis/Apheresis Catheter cleared by the FDA?
Cascade Hemodialysis/Apheresis Catheter (K130851) received a 510(k) decision of Unknown on January 9, 2014, 288 days after the submission was received.
What is the product code of K130851?
The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.