Non-Invasive Central Venous Manometer
The Non-Invasive Central Venous Manometer is a cardiovascular device that measures central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near-infrared or related optical sensing technology, without the need for invasive catheter placement. It falls under the Cardiovascular medical specialty and is classified as a Class 2 device under regulation 870.1140, requiring 510(k) premarket notification. Non-invasive CVP measurement reduces the risks associated with central venous catheterization. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PFA
- Device Class
- FDA class 2
- Regulation Number
- 870.1140
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.
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 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.