FDA product code NPG: Catheter, Infusion, Syringe
NPG is the FDA product code for catheter, infusion, syringe. It is a Class II device, regulated under 21 CFR 870.1210 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under NPG, 1 in the last five years. The average 510(k) review took 265 days (median 265).
Definition
To provide physician specified fluids both perivascular or intraluminal to the perivascular space.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Infusion, Syringe |
| Device class | Class II |
| Regulation | 21 CFR 870.1210 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for NPG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 265 |
Compare with all 510(k) review times · Search every NPG clearance
Top NPG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intervene, Inc. | 1 | 2023-04-13 |
Most recent NPG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222185 | Intervene, Inc. | Stratus Infusion Catheter | 2023-04-13 | 265 |
Recalls for NPG devices
openFDA lists no recalls for product code NPG.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
Frequently asked questions
What is FDA product code NPG?
NPG is the FDA product code for catheter, infusion, syringe. It is a Class II device, regulated under 21 CFR 870.1210 and reviewed by the Cardiovascular panel.
What device class is NPG?
Class II, regulation 21 CFR 870.1210. Typical premarket route: 510(k).
How long does a 510(k) take for product code NPG?
Across 1 cleared submissions the average was 265 days from receipt to decision (median 265).
Which companies have the most NPG clearances?
Intervene, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NPG
- Run a recall and safety report across every NPG manufacturer
- Watch product code NPG 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times