FDA Product Code PND: Midline Catheter
The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.
Leading manufacturers include C.R. Bard, Inc. and Terumo Medical Products Hangzhou Co., Ltd..
FDA 510(k) Cleared Midline Catheter Devices (Product Code PND)
About Product Code PND - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code PND since 2016, with 13 receiving FDA clearance (average review time: 160 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for PND submissions have been consistent, averaging 140 days recently vs 162 days historically.
PND devices are reviewed by the General Hospital panel. Browse all General Hospital devices →