510(k) K153359
K153359 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BardPort®, SlimPort®, and X-Port® Implanted Ports". The FDA issued a decision of Substantially Equivalent on May 20, 2016. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2016
- Date Received
- November 20, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Port & Catheter, Implanted, Subcutaneous, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5965
- Review Panel
- HO
- Submission Type