Cardiac Catheterization Kit
The Cardiac Catheterization Kit (product code OES) is a cardiovascular convenience kit containing components assembled for use during cardiac catheterization procedures, such as vascular access and hemodynamic measurement. Established under the May 1997 FDA Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) submission if it meets all criteria in the guidance. This device is FDA Class 2 under regulation 870.1200 in the Cardiovascular specialty. It carries no implant or life-sustaining flags.
Research product code OES in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OES
- Device Class
- FDA class 2
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.