Thermodilution Catheter
FDA 510(k) K840992 · Gould, Inc.
510(k) numberK840992
Submission
- Device name
- Thermodilution Catheter
- Applicant
- Gould, Inc.
Walker, MI, US - Received
- March 7, 1984
- Decision date
- May 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRB – Probe, Thermodilution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1915
- Specialty
- Cardiovascular
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| K902627 | Interflo Medical Model Oxi/Co Fila. Thermo. Cath.KRB · Traditional | Biometric Research Institute, Inc. | 02/25/1991SE |
| K900710 | Interflo Medical Model F-1 Thermodilution CatheterKRB · Traditional | Intec Medical, Inc. | 10/19/1990SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K911935 | Cardiac Electrophysical Lead Selector, ModifiedDRR · Traditional | 07/22/1991SE |
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| K860805 | Pressure Monitor Cath Models SP5325,SP5327,SP5337DQO · Traditional | 05/08/1986SE |
| K855145 | Model:Ta-Rose Resonant Overshoot EliminatorDRS · Traditional | 02/26/1986SE |
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| K851486 | Gould Disposable Transducer & Accessories-DtxDRS · Traditional | 10/17/1985SE |
| K850114 | C/Pes 9201, ECG Stress Testing SysDRT · Traditional | 02/22/1985SE |
| K850113 | C/Pes 9103, ECG Stress Testing SystemDRT · Traditional | 02/08/1985SE |
| K843555 | Cardiac Computer SP1445DXG · Traditional | 02/01/1985SE |
| K843969 | Model P23XL Physiological Pressure TransducerDXO · Traditional | 01/23/1985SE |
Questions and answers
When was Thermodilution Catheter cleared by the FDA?
Thermodilution Catheter (K840992) received a 510(k) decision of Substantially Equivalent on May 23, 1984, 77 days after the submission was received.
What is the product code of K840992?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.