Probe, Test, Heart-Valve
The Heart Valve Test Probe (product code LXN) is a cardiovascular instrument used intraoperatively to assess the function, sizing, or fit of a prosthetic or repaired heart valve before final placement. Regulated under 21 CFR 870.4500 and classified as a Class 1 device subject only to general controls, it falls under the Cardiovascular medical specialty. It is not an implant, is not life-sustaining, and is not GMP-exempt.
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Basic Information
- Product Code
- LXN
- Device Class
- FDA class 1
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.