Cobe Cop Filter Cardiopulmonary Prebypass Filter
FDA 510(k) K850139 · Rapid Diagnostic Laboratories, Inc.
510(k) numberK850139
Submission
- Device name
- Cobe Cop Filter Cardiopulmonary Prebypass Filter
- Applicant
- Rapid Diagnostic Laboratories, Inc.
Lakewood, CO, US - Received
- January 14, 1985
- Decision date
- April 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRJ – Filter, Prebypass, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4280
- Specialty
- Cardiovascular
Other 510(k)s with product code KRJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990276 | Porous Media DPB30 Series Disposable Pre-Bypass FilterKRJ · Traditional | Porous Media Corp. | 10/01/1999SE |
| K982385 | Porous Media DPB20 Series Disposable Pre-Bypass FilterKRJ · Traditional | Porous Media Corp. | 02/01/1999SE |
| K940126 | Avecor Pre-Bypass FilterKRJ · Traditional | Avecor Cardiovascular, Inc. | 06/28/1994SE |
| K900672 | Prebypass Filter, Cat. No. FPB-5KRJ · Traditional | American Omni Medical, Inc. | 04/03/1990SE |
| K885154 | Intersept* Crystalloid Cardioplegia Deliv. SystemKRJ · Traditional | Medtronic Blood Systems, Inc. | 02/22/1989SE |
| K884390 | Intersept* Crystalloid Cardioplegia FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 12/21/1988SE |
| K884244 | Intersept* Prebypass FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 12/05/1988SE |
| K883086 | Intersept*Prebypass FilterKRJ · Traditional | Medtronic Blood Systems, Inc. | 09/16/1988SE |
| K875094 | Ultipor Pre-Bypass Plus Filter W/Posidyne MembraneKRJ · Traditional | Pall Biomedical Products Co. | 02/29/1988SE |
| K871350 | Prebypass FilterKRJ · Traditional | American Omni Medical, Inc. | 06/08/1987SE |
More from American Omni Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K903909 | Blind Controls for Drugs of Abuse TestingDIF · Traditional | 10/26/1990SE |
| K890030 | New Low Level Drug Mixture ControlDIF · Traditional | 01/23/1989SE |
| K875216 | High Performance CalibratorsDKB · Traditional | 06/22/1988SE |
| K871694 | Hyperformance Controls (Hp-Controls)DIF · Traditional | 07/07/1987SE |
| K863117 | High Performance Cannabinoid ControlsLAS · Traditional | 09/25/1986SE |
Questions and answers
When was Cobe Cop Filter Cardiopulmonary Prebypass Filter cleared by the FDA?
Cobe Cop Filter Cardiopulmonary Prebypass Filter (K850139) received a 510(k) decision of Substantially Equivalent on April 10, 1985, 86 days after the submission was received.
What is the product code of K850139?
The FDA product code is KRJ – Filter, Prebypass, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4280.