Valve, Pressure Relief, Blood Oxygenator
FDA 510(k) K770681 · Scimed Life Systems, Inc.
510(k) numberK770681
Submission
- Device name
- Valve, Pressure Relief, Blood Oxygenator
- Applicant
- Scimed Life Systems, Inc.
Mchenry, IL, US - Received
- April 11, 1977
- Decision date
- April 26, 1977
- 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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| 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 |
| K884640 | Cardioplegia Overpressure Valve CPOP-350 & 700KRI · Traditional | American Omni Medical, Inc. | 01/24/1989SE |
| K874605 | Hi-Lo Temp(R) Myocardial Temperature SensorKRI · Traditional | Mallinckrodt Critical Care | 02/02/1988SE |
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Questions and answers
When was Valve, Pressure Relief, Blood Oxygenator cleared by the FDA?
Valve, Pressure Relief, Blood Oxygenator (K770681) received a 510(k) decision of Substantially Equivalent on April 26, 1977, 15 days after the submission was received.
What is the product code of K770681?
The FDA product code is KRI – Accessory Equipment, Cardiopulmonary Bypass, a Class I (low risk) device regulated under 21 CFR 870.4200.