FDA product code PUM: Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
PUM is the FDA product code for temporary catheter, embolic protection, transcatheter intracardiac procedures. It is a Class II device, regulated under 21 CFR 870.1251 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under PUM, 1 in the last five years, from 2 different applicants. The average 510(k) review took 136 days (median 136); 109 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Embolic protection for transcatheter intracardiac procedures
Classification
| Field | Value |
|---|---|
| Device name | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures |
| Device class | Class II |
| Regulation | 21 CFR 870.1251 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for PUM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 163 |
| 2026 | 1 | 109 |
Compare with all 510(k) review times · Search every PUM clearance
Top PUM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Emboline, Inc. | 1 | 2026-09-08 |
| Boston Scientific Corporation | 1 | 2020-02-19 |
Most recent PUM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261715 | Emboline, Inc. | Emboliner Embolic Protection System (EPC-03) | 2026-09-08 | 109 |
| K192460 | Boston Scientific Corporation | Sentinel Cerebral Protection System | 2020-02-19 | 163 |
Recalls for PUM devices
openFDA lists no recalls for product code PUM.
Frequently asked questions
What is FDA product code PUM?
PUM is the FDA product code for temporary catheter, embolic protection, transcatheter intracardiac procedures. It is a Class II device, regulated under 21 CFR 870.1251 and reviewed by the Cardiovascular panel.
What device class is PUM?
Class II, regulation 21 CFR 870.1251. Typical premarket route: 510(k).
How long does a 510(k) take for product code PUM?
Across 2 cleared submissions the average was 136 days from receipt to decision (median 136).
Which companies have the most PUM clearances?
Emboline, Inc. (1); Boston Scientific Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PUM
- Run a recall and safety report across every PUM manufacturer
- Watch product code PUM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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