Elecath Ventricular Pacing Thermal Dilution Cath
FDA 510(k) K844022 · Electro-Catheter Corp.
510(k) numberK844022
Submission
- Device name
- Elecath Ventricular Pacing Thermal Dilution Cath
- Applicant
- Electro-Catheter Corp.
Rahway, NJ, US - Received
- October 15, 1984
- Decision date
- November 20, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K934785 | MultipaceLDF · Traditional | 07/27/1995SE |
| K943257 | Tip Deflector (Genesis)DRF · Traditional | 04/19/1995SE |
| K933451 | Open Tip Multi-Electrode Catheter, ModificationDRF · Traditional | 04/19/1995SE |
| K933450 | Closed Tip Multi-Electrode Catheter, ModificationDRF · Traditional | 04/19/1995SE |
| K934787 | Silicore Semi-FloaterLDF · Traditional | 02/24/1995SE |
| K874154 | Elecath(R) Transesophageal Pacing CatheterKNT · Traditional | 04/29/1988SE |
| K854511 | Elecath Percutaneous Left Atrial Cannulation SetDQX · Traditional | 02/10/1986SE |
| K854975 | Elecath Pulsatile Perfusion PumpKFM · Traditional | 01/15/1986SE |
| K850065 | Elecath Torkfloat Pacing ProbeDTB · Traditional | 04/10/1985SE |
| K850324 | Elecath Open Tip Bipolar Pacing CatheterLDF · Traditional | 03/27/1985SE |
Questions and answers
When was Elecath Ventricular Pacing Thermal Dilution Cath cleared by the FDA?
Elecath Ventricular Pacing Thermal Dilution Cath (K844022) received a 510(k) decision of Substantially Equivalent on November 20, 1984, 36 days after the submission was received.
What is the product code of K844022?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.