Product Code: DXP
FDA class 2
21 CFR 870.2890
Transducer, Vessel Occlusion
Cardiovascular
The Vessel Occlusion Transducer is a cardiovascular device used to measure pressure changes associated with temporary occlusion of a blood vessel, commonly used in hemodynamic assessment. It is classified as FDA Class 2, indicating moderate risk, and must receive 510(k) clearance before it may be marketed. The product code is DXP and the applicable regulation is 21 CFR 870.2890, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
8
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Basic Information
- Product Code
- DXP
- Device Class
- FDA class 2
- Regulation Number
- 870.2890
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.