Data / Medical devices / Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures (PUM): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures (product code PUM, Class 2, 21 CFR 870.1251). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on September 8, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PUM
- Device class
- 2
- Regulation
- 870.1251
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| Costa Rica | 3 |
| United States | 2 |
Makers of Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 1 | February 19, 2020 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 1 | February 19, 2020 | 0 | 0 | 0 | api.fda.gov |
| Emboline Inc | Santa Cruz, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | September 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Biomerics Alajuela | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nitinol Devices & Components Costa Rica, S. R. L. | El Coyol Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.