Keystone Medical Schon XL Soft-Line Double Lument Catheter. Keystone Medical 12 F Duo-Flow and 14F Duo-Flow 400 XL Cath
FDA 510(k) K001958 · Keystone Medical
510(k) numberK001958
Submission
- Device name
- Keystone Medical Schon XL Soft-Line Double Lument Catheter. Keystone Medical 12 F Duo-Flow and 14F Duo-Flow 400 XL Cath
- Applicant
- Keystone Medical
Great Neck, NY, US - Received
- June 27, 2000
- Decision date
- September 25, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MPB – Catheter, Hemodialysis, Non-Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code MPB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen CatheterMPB · Traditional | Medical Components, Inc. | 08/12/2025SE |
| K200426 | Acute Dual Lumen Hemodialysis CatheterMPB · Traditional | Health Line International Corporation | 12/24/2020SESK |
| K192807 | Duo-Flow Side x Side Double Lumen CatheterMPB · Traditional | Medical Components, Inc. (dba MedComp) | 04/23/2020SE |
| K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…MPB · Traditional | Covidien, LLC | 01/17/2020SEKD |
| K163458 | Zenysis Short-Term Dialysis CatheterMPB · Traditional | C.R. Bard, Inc. | 04/04/2017SEKD |
| K161504 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayMPB · Special | Cook Incorporated | 01/06/2017SEKD |
| K153190 | Zenysis Short-Term Dialysis CatheterMPB · Traditional | C.R. Bard, Inc. | 01/05/2016SE |
| K122091 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute…MPB · Traditional | Cook, Inc. | 07/29/2013SESK |
| K120674 | Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterMPB · Special | Covidien | 04/04/2012SESK |
| K110793 | Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization KitsMPB · Traditional | Ameco Medical Industries | 12/16/2011SE |
More from Ameco Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K011860 | KEYST0NE Medical Picc CatheterFOZ · Traditional | 06/27/2001SE |
Questions and answers
When was Keystone Medical Schon XL Soft-Line Double Lument Catheter. Keystone Medical 12 F Duo-Flow and 14F Duo-Flow 400 XL Cath cleared by the FDA?
Keystone Medical Schon XL Soft-Line Double Lument Catheter. Keystone Medical 12 F Duo-Flow and 14F Duo-Flow 400 XL Cath (K001958) received a 510(k) decision of Substantially Equivalent on September 25, 2000, 90 days after the submission was received.
What is the product code of K001958?
The FDA product code is MPB – Catheter, Hemodialysis, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.