Edwards Lifesciences Left Atrial Pressure Monitor Catheter
FDA 510(k) K110103 · Edwards Lifesciences, LLC
510(k) numberK110103
Submission
- Device name
- Edwards Lifesciences Left Atrial Pressure Monitor Catheter
- Applicant
- Edwards Lifesciences, LLC
Draper, UT, US - Received
- January 13, 2011
- Decision date
- February 11, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
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Questions and answers
When was Edwards Lifesciences Left Atrial Pressure Monitor Catheter cleared by the FDA?
Edwards Lifesciences Left Atrial Pressure Monitor Catheter (K110103) received a 510(k) decision of Substantially Equivalent on February 11, 2011, 29 days after the submission was received.
What is the product code of K110103?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.