NPG · Class II · 21 CFR 870.1210

FDA Product Code NPG: Catheter, Infusion, Syringe

To Provide Physician Specified Fluids Both Perivascular Or Intraluminal To The Perivascular Space.

Leading manufacturers include Intervene, Inc..

1
Total
1
Cleared
265d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Catheter, Infusion, Syringe Devices (Product Code NPG)

1 devices
1–1 of 1
Cleared Apr 13, 2023
Stratus Infusion Catheter
K222185
Intervene, Inc.
Cardiovascular · 265d

About Product Code NPG - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code NPG since 2023, with 1 receiving FDA clearance (average review time: 265 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

NPG devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →