Continucath
FDA 510(k) K860808 · Orange Medical Instruments, Inc.
510(k) numberK860808
Submission
- Device name
- Continucath
- Applicant
- Orange Medical Instruments, Inc.
Buckinghamshire, England, GB - Received
- March 4, 1986
- Decision date
- March 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1200
- Specialty
- Anesthesiology
Other 510(k)s with product code CCE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K935778 | Via 1-01 Infusion Pump/Blood Chemistry SystemCCE · Traditional | Via Medical Corp. | 12/05/1996SEKD |
| K912145 | System Athena-Product Enhancements, AnesthesiaCCE · Traditional | S & W Medico Teknik | 05/05/1992SE |
| K910453 | Tops Needle Tip Probe & PVC Tip ProbeCCE · Traditional | Baxter Healthcare Corp | 08/13/1991SE |
| K905397 | PB3200 Intra-Arterial Blood Gas Monitoring SystemCCE · Traditional | Puritan Bennett Corp. | 05/14/1991SE |
| K896311 | Optex Blood Gas Monitoring SystemCCE · Traditional | Optex Biomedical | 01/03/1990SE |
| K890624 | Tissue Oxygen Monitor System, Model IICCE · Traditional | Baxter Healthcare Corp | 12/22/1989SE |
| K895150 | Continucath 1000 Intravascular Oxygen MonitoringCCE · Traditional | Shiley, Inc. | 11/28/1989SE |
| K895149 | Neocath 1000 Umbilical Artery Oxygen Monitoring SyCCE · Traditional | Shiley, Inc. | 11/28/1989SE |
| K884063 | Bard Abg 100 Intravascular Oxygen Monitor SystemCCE · Traditional | C.R. Bard, Inc. | 12/16/1988SE |
| K875225 | Umbilical Artery Oxygen SensorCCE · Traditional | Ohmeda Medical | 03/04/1988SE |
More from Ohmeda Medical
| 510(k) | Device | Decision |
|---|---|---|
| K851822 | Beta Scan Trends MeterCGA · Traditional | 10/03/1985SE |
| K844796 | Micro-Beta U100 SyringeFMF · Traditional | 12/18/1984SE |
| K843882 | Trends LancetKMK · Traditional | 11/05/1984SE |
| K841369 | Beta Scan DrystixCGA · Traditional | 08/23/1984SE |
| K833705 | Betaject BD U100FMI · Traditional | 05/09/1984SE |
| K833706 | Click-Count U100 Insulin SyringeFMF · Traditional | 04/05/1984SE |
| K832691 | Beta Scan Reagent StripCGA · Traditional | 11/14/1983SE |
| K832793 | Neocath 1000 W/HepcoteCCE · Traditional | 09/26/1983SE |
| K831897 | Beta I Programmable Infusion PumpFRN · Traditional | 08/12/1983SE |
| K831523 | Beta Scan Normal Control SolutionJJX · Traditional | 07/19/1983SE |
Questions and answers
When was Continucath cleared by the FDA?
Continucath (K860808) received a 510(k) decision of Substantially Equivalent on March 13, 1986, 9 days after the submission was received.
What is the product code of K860808?
The FDA product code is CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1200.