510(k) K153393
K153393 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "PowerMidline Catheter". The FDA issued a decision of Substantially Equivalent on June 28, 2016. The device falls under product code PND (Midline Catheter), a Class II device regulated under 21 CFR 880.5200. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2016
- Date Received
- November 24, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Midline Catheter
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type
The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.