Perfusion Monitor
FDA 510(k) K900860 · Cardio Metrics, Inc.
510(k) numberK900860
Submission
- Device name
- Perfusion Monitor
- Applicant
- Cardio Metrics, Inc.
Sugar Land, TX, US - Received
- February 23, 1990
- Decision date
- August 14, 1990
- 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 |
| 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 |
| K822000 | Extracorporeal Blood Gas SystemDTY · Traditional | Cardiovascular Devices, Inc. | 12/22/1982SE |
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| K955551 | CARDI0METRICS Flow Wire XT Doppler Guide Model 1403, 1404DQX · Traditional | 02/28/1996SE |
| K954913 | Cardiometrics Accutrac Intravascular Guide Wire (Modification)DQX · Traditional | 11/07/1995SE |
| K952562 | Cardiometrics Accutrac Intravascular Guide WireDQX · Traditional | 08/29/1995SE |
| K943022 | Cardiometrics Flowire Doppler Guide WireDQX · Traditional | 09/19/1994SE |
| K940984 | Cardiometrics Dualflow Switch BoxDQX · Traditional | 08/18/1994SE |
| K933320 | Cardiometrics Flomap and Flomod Ultrasound InstrumentIYO · Traditional | 08/17/1994SE |
Questions and answers
When was Perfusion Monitor cleared by the FDA?
Perfusion Monitor (K900860) received a 510(k) decision of Substantially Equivalent on August 14, 1990, 172 days after the submission was received.
What is the product code of K900860?
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.