510(k) K993024
K993024 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "CELSITE IMPLANTABLE PORT WITH VALVED CATHETER". The FDA issued a decision of Substantially Equivalent on March 13, 2000. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2000
- Date Received
- September 9, 1999
- Clearance Type
- Traditional
- 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