FDA product code PNS: Short-Term Intravascular Filter Catheter
PNS is the FDA product code for short-term intravascular filter catheter. It is a Class II device, regulated under 21 CFR 870.3375 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under PNS. The average 510(k) review took 132 days (median 132).
Definition
For short-term prevention of pulmonary embolism (PE)
Classification
| Field | Value |
|---|---|
| Device name | Short-Term Intravascular Filter Catheter |
| Device class | Class II |
| Regulation | 21 CFR 870.3375 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every PNS clearance
Top PNS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio2 Medical, Inc. | 1 | 2016-07-28 |
Most recent PNS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160747 | Bio2 Medical, Inc. | Angel Catheter | 2016-07-28 | 132 |
Recalls for PNS devices
openFDA lists no recalls for product code PNS.
Frequently asked questions
What is FDA product code PNS?
PNS is the FDA product code for short-term intravascular filter catheter. It is a Class II device, regulated under 21 CFR 870.3375 and reviewed by the Cardiovascular panel.
What device class is PNS?
Class II, regulation 21 CFR 870.3375. Typical premarket route: 510(k).
How long does a 510(k) take for product code PNS?
Across 1 cleared submissions the average was 132 days from receipt to decision (median 132).
Which companies have the most PNS clearances?
Bio2 Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PNS
- Run a recall and safety report across every PNS manufacturer
- Watch product code PNS 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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