Prebypass Filter, Cat. No. FPB-5
FDA 510(k) K900672 · American Omni Medical, Inc.
510(k) numberK900672
Submission
- Device name
- Prebypass Filter, Cat. No. FPB-5
- Applicant
- American Omni Medical, Inc.
Costa Mesa, CA, US - Received
- February 13, 1990
- Decision date
- April 3, 1990
- 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 |
| 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 |
| K861226 | Interface Crystalloid Cardioplegic Filter Model 70KRJ · Traditional | Medical, Inc. | 06/02/1986SE |
More from Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922781 | Flow Conrol ValveMJJ · Traditional | 03/08/1993SE |
| K922356 | Flow Control Valve, Cat. No. ACV-38MJJ · Traditional | 02/12/1993SE |
| K884893 | Cardiotomy Reservoir Valve No. CRV-30 or PCRV-25KRI · Traditional | 01/30/1989SE |
| K884640 | Cardioplegia Overpressure Valve CPOP-350 & 700KRI · Traditional | 01/24/1989SE |
| K873316 | Bubble Trap-Filter Cat. No B180F37DTM · Traditional | 07/14/1988SE |
| K875080 | Air Vent Line Cat. No. AVL-36DTM · Traditional | 02/29/1988SE |
| K873802 | Pressure Barrier Kit Cat. No. PBK-3DXS · Traditional | 11/06/1987SE |
| K873610 | Pediatric Bubble Trap Cat. No. B-100BSY · Traditional | 11/05/1987SE |
| K873488 | Silent Guard Cat. No. SG-10DTL · Traditional | 10/07/1987SE |
| K871632 | Nasogastric VoicetubeBTR · Traditional | 09/16/1987SE |
Questions and answers
When was Prebypass Filter, Cat. No. FPB-5 cleared by the FDA?
Prebypass Filter, Cat. No. FPB-5 (K900672) received a 510(k) decision of Substantially Equivalent on April 3, 1990, 49 days after the submission was received.
What is the product code of K900672?
The FDA product code is KRJ – Filter, Prebypass, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4280.