Cardioplegia Overpressure Valve CPOP-350 & 700
FDA 510(k) K884640 · American Omni Medical, Inc.
510(k) numberK884640
Submission
- Device name
- Cardioplegia Overpressure Valve CPOP-350 & 700
- Applicant
- American Omni Medical, Inc.
Costa Mesa, CA, US - Received
- November 7, 1988
- Decision date
- January 24, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRI – Accessory Equipment, Cardiopulmonary Bypass
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4200
- Specialty
- Cardiovascular
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| K934782 | Ammex Tubing OrganizerKRI · Traditional | Ammex Cardiopulmonary Corp. | 11/18/1993SE |
| K926233 | CARDIO2 CycleKRI · Traditional | Ergometrix, Inc. | 06/04/1993SE |
| K922404 | Tube GripKRI · Traditional | Georgia Medical Products, Inc. | 11/23/1992SE |
| K892856 | Newmark(Tm) Coronary Artery Bypass Graft MarkersKRI · Traditional | Acacia Laboratories, Inc. | 11/08/1989SE |
| K884893 | Cardiotomy Reservoir Valve No. CRV-30 or PCRV-25KRI · Traditional | American Omni Medical, Inc. | 01/30/1989SE |
| K874605 | Hi-Lo Temp(R) Myocardial Temperature SensorKRI · Traditional | Mallinckrodt Critical Care | 02/02/1988SE |
| K874925 | Cpe 2000 Cardio Pulmonary ErgometerKRI · Traditional | Medical Graphics Corp. | 01/19/1988SE |
More from Medical Graphics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K922781 | Flow Conrol ValveMJJ · Traditional | 03/08/1993SE |
| K922356 | Flow Control Valve, Cat. No. ACV-38MJJ · Traditional | 02/12/1993SE |
| K900672 | Prebypass Filter, Cat. No. FPB-5KRJ · Traditional | 04/03/1990SE |
| K884893 | Cardiotomy Reservoir Valve No. CRV-30 or PCRV-25KRI · Traditional | 01/30/1989SE |
| 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 Cardioplegia Overpressure Valve CPOP-350 & 700 cleared by the FDA?
Cardioplegia Overpressure Valve CPOP-350 & 700 (K884640) received a 510(k) decision of Substantially Equivalent on January 24, 1989, 78 days after the submission was received.
What is the product code of K884640?
The FDA product code is KRI – Accessory Equipment, Cardiopulmonary Bypass, a Class I (low risk) device regulated under 21 CFR 870.4200.