Catheter, Pressure Monitoring, Cardiac
The Cardiac Pressure Monitoring Catheter (product code OBI) is a cardiovascular device used to measure pressure within the cardiovascular system, supporting hemodynamic assessment during diagnostic or interventional procedures. Accurate intravascular pressure measurement is essential for evaluating cardiac function and guiding clinical decision-making. This device is FDA Class 2 under regulation 870.1200 in the Cardiovascular specialty, requiring 510(k) premarket clearance demonstrating substantial equivalence to a predicate device. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OBI
- Device Class
- FDA class 2
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
To measure pressure within the cardiovascular system.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190473 | ACIST RXi System and Navvus II Catheter | Sep 13, 2019 | Substantially Equivalent | Acist Medical Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.