Elecath Percutaneous Left Atrial Cannulation Set
FDA 510(k) K854511 · Electro-Catheter Corp.
510(k) numberK854511
Submission
- Device name
- Elecath Percutaneous Left Atrial Cannulation Set
- Applicant
- Electro-Catheter Corp.
Rahway, NJ, US - Received
- November 12, 1985
- Decision date
- February 10, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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More from Solo Pace, Inc.
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|---|---|---|
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| 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 |
| 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 |
| K844682 | Elecath Cardiac Output ComputerDXG · Traditional | 03/06/1985SE |
Questions and answers
When was Elecath Percutaneous Left Atrial Cannulation Set cleared by the FDA?
Elecath Percutaneous Left Atrial Cannulation Set (K854511) received a 510(k) decision of Substantially Equivalent on February 10, 1986, 90 days after the submission was received.
What is the product code of K854511?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.