Cobe Single-Needle Controller #18-756
FDA 510(k) K820173 · Cobe Laboratories, Inc.
510(k) numberK820173
Submission
- Device name
- Cobe Single-Needle Controller #18-756
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- January 21, 1982
- Decision date
- March 23, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FIF – Set, Dialysis, Single Needle With Uni-Directional Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873279 | 8810 Pump-Pump Single Needle DeviceFIF · Traditional | Cd Medical, Inc. | 10/23/1987SE |
| K802230 | Bellco Single Needle Double Head PumpFIF · Traditional | Cardio Med Supplies, Inc. | 12/22/1980SE |
| K801967 | Medcomp Femoral Vein CatheterFIF · Traditional | Medical Components, Inc. | 09/26/1980SE |
| K792174 | Model DM 353 & DM-353-L Single NeedleFIF · Traditional | Extracorporeal Medical Specialities, Inc. | 11/16/1979SE |
| K772147 | GW 35 Guide WireFIF · Traditional | Sorensen Research | 11/28/1977SE |
More from Sorensen Research
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|---|---|---|
| K923272 | Cobe Cms-Hf Hollow Fiber Membrane OxygenatorDTZ · Traditional | 05/11/1993SE |
| K900105 | Cobe Spectra Blood Component Separator TherapeuticLKN · Traditional | 03/22/1991SE |
| K905793 | Cobe Centry 2 Bicart Option KitFKP · Traditional | 02/12/1991SE |
| K905388 | Cobe Centrysystem 3 Bicart Option KitFKP · Traditional | 02/11/1991SE |
| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | 12/27/1990SE |
| K902631 | Cobe ICU Conversion KitDTN · Traditional | 12/17/1990SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | 12/17/1990SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
| K902758 | Cobe Saturation/Hematocrit Monitor W/ Fiber OpticDQA · Traditional | 08/23/1990SE |
| K902759 | Cobe Closed Wound Drainage KitCAC · Traditional | 07/18/1990SE |
Questions and answers
When was Cobe Single-Needle Controller #18-756 cleared by the FDA?
Cobe Single-Needle Controller #18-756 (K820173) received a 510(k) decision of Substantially Equivalent on March 23, 1982, 61 days after the submission was received.
What is the product code of K820173?
The FDA product code is FIF – Set, Dialysis, Single Needle With Uni-Directional Pump, a Class II (moderate risk) device regulated under 21 CFR 876.5820.