Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
FDA 510(k) K122091 · Cook, Inc.
510(k) numberK122091
Submission
- Device name
- Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- July 16, 2012
- Decision date
- July 29, 2013
- Decision
- Unknown (SESK)
- 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 |
| 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 |
| K102833 | Disposable Hemodialysis Access Catheter SetsMPB · Traditional | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 11/18/2011SE |
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Questions and answers
When was Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray cleared by the FDA?
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray (K122091) received a 510(k) decision of Unknown on July 29, 2013, 378 days after the submission was received.
What is the product code of K122091?
The FDA product code is MPB – Catheter, Hemodialysis, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.