Extracorporeal Blood Gas System
FDA 510(k) K822000 · Cardiovascular Devices, Inc.
510(k) numberK822000
Submission
- Device name
- Extracorporeal Blood Gas System
- Applicant
- Cardiovascular Devices, Inc.
Walker, MI, US - Received
- July 7, 1982
- Decision date
- December 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTY – Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4410
- Specialty
- Cardiovascular
Other 510(k)s with product code DTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093650 | Biotrend Oxygen Saturation and Hematocrit SystemDTY · Traditional | Medtronic, Inc. | 02/17/2010SE |
| K963698 | CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4DTY · Traditional | International Biophysics Corp. | 03/20/1997SE |
| K954501 | Biotrend Oxygen Saturation & Hematocrit SystemDTY · Traditional | Medtronic Bio-Medicus, Inc. | 01/16/1996SE |
| K902654 | Cdi (TM) System 100 Monitoring SystemDTY · Traditional | 3M Health Care, Ltd. | 11/05/1990SE |
| K900860 | Perfusion MonitorDTY · Traditional | Cardio Metrics, Inc. | 08/14/1990SE |
| K864703 | Modified Gas-Stat(Tm) Monitoring SystemDTY · Traditional | Cardiovascular Devices, Inc. | 02/19/1987SE |
| K840749 | Gast Stat Monitoring SystemDTY · Traditional | Cardiovascular Devices, Inc. | 04/17/1984SE |
More from Cardiovascular Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K890113 | The Cdi(R) System 400DJY · Traditional | 05/23/1989SE |
| K884228 | Cdi(R) 2000 Blood Gas MonitorCBZ · Traditional | 01/30/1989SE |
| K871221 | Cdi(Tm) Extracorporeal Blood Gas System 300DRY · Traditional | 06/05/1987SE |
| K864703 | Modified Gas-Stat(Tm) Monitoring SystemDTY · Traditional | 02/19/1987SE |
| K843912 | Intravascular Blood Gas SystemCCE · Traditional | 01/10/1985SE |
| K840749 | Gast Stat Monitoring SystemDTY · Traditional | 04/17/1984SE |
| K831225 | Gas-Stat Monitoring SystemDRY · Traditional | 05/27/1983SE |
Questions and answers
When was Extracorporeal Blood Gas System cleared by the FDA?
Extracorporeal Blood Gas System (K822000) received a 510(k) decision of Substantially Equivalent on December 22, 1982, 168 days after the submission was received.
What is the product code of K822000?
The FDA product code is DTY – Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4410.