Ultrastream Chronic Hemodialysis Catheter
FDA 510(k) K102043 · Rex Medical
510(k) numberK102043
Submission
- Device name
- Ultrastream Chronic Hemodialysis Catheter
- Applicant
- Rex Medical
Great Neck, NY, US - Received
- July 20, 2010
- Decision date
- November 18, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K120346 | Cleaner Rotational Thrombectomy SystemMCW · Traditional | 06/01/2012SE |
| K113103 | Splitwire Percutaneous Transluminal Angioplasty Scoring DevicePNO · Traditional | 05/22/2012SE |
| K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)MCW · Traditional | 02/18/2010SE |
| K081410 | Option Vena Cava FilterDTK · Traditional | 06/04/2009SE |
| K071422 | 15.5F Hemo-Stream Hemodialysis Catheter SetMSD · Traditional | 08/22/2007SESK |
| K051468 | Inner-Lock Introducer SheathDYB · Special | 08/04/2005SE |
| K040252 | Cleaner Rotational Thrombectomy System KitMCW · Special | 02/26/2004SE |
| K033793 | Cleaner II Rotational Thrombectomy SystemMCW · Traditional | 12/16/2003SE |
| K032569 | Short Introducer SheathDYB · Special | 09/16/2003SE |
| K031610 | Rex Medical Cleaner Rotational Thrombectomy SystemMCW · Traditional | 05/27/2003SE |
Questions and answers
When was Ultrastream Chronic Hemodialysis Catheter cleared by the FDA?
Ultrastream Chronic Hemodialysis Catheter (K102043) received a 510(k) decision of Substantially Equivalent on November 18, 2010, 121 days after the submission was received.
What is the product code of K102043?
The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.