Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
The Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures is a cardiovascular device used to provide embolic protection during transcatheter intracardiac procedures such as transcatheter aortic valve replacement (TAVR), capturing debris and emboli that may be dislodged during the procedure to reduce the risk of stroke or other embolic complications. It is classified as FDA Class II under regulation 21 CFR 870.1251, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PUM and it falls under the Cardiovascular medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PUM
- Device Class
- FDA class 2
- Regulation Number
- 870.1251
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Embolic protection for transcatheter intracardiac procedures
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 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.