510(k) K242328
K242328 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports". The FDA issued a decision of Substantially Equivalent on October 31, 2024. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2024
- Date Received
- August 6, 2024
- 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