Drake Willock System 1000 Dialysate Delivery Syst
FDA 510(k) K910215 · Cd Medical, Inc.
510(k) numberK910215
Submission
- Device name
- Drake Willock System 1000 Dialysate Delivery Syst
- Applicant
- Cd Medical, Inc.
Miami Lakes, FL, US - Received
- January 17, 1991
- Decision date
- April 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKP – System, Dialysate Delivery, Single Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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More from Integrated Biomedical Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925654 | CD Home Dialyservice Hemodialysis TrayKOC · Traditional | 03/30/1994SEKD |
| K901520 | Wurtz Choley Clip (TM)GBZ · Traditional | 06/26/1990SE |
| K894106 | Drake Willock Reverse Osmosis Water Treatment SystFIP · Traditional | 11/08/1989SE |
| K884353 | Ultrx(Tm) 850 Artificial KidneyKDI · Traditional | 12/08/1988SE |
| K880459 | 480 High-Flow Ultrafiltration Control DialysateFKP · Traditional | 04/13/1988SE |
| K873279 | 8810 Pump-Pump Single Needle DeviceFIF · Traditional | 10/23/1987SE |
| K864784 | Seraflo(Tm) Bloodlines for HemodialysisFJK · Traditional | 01/20/1987SE |
| K862304 | Drake Willock Central Dialysate Delivery SystemFKQ · Traditional | 09/09/1986SE |
| K853513 | Drake Willock 480 Uf Control Idalysate Delivery SyFKP · Traditional | 11/06/1985SE |
| K844185 | Modified C-DakKOC · Traditional | 01/03/1985SE |
Questions and answers
When was Drake Willock System 1000 Dialysate Delivery Syst cleared by the FDA?
Drake Willock System 1000 Dialysate Delivery Syst (K910215) received a 510(k) decision of Substantially Equivalent on April 9, 1991, 82 days after the submission was received.
What is the product code of K910215?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.