510(k) K850967
K850967 is an FDA 510(k) premarket notification submitted by Cormed, Inc., Sub. C.R.Bard, Inc. for the device "STERILE CORMED MEDIPORT". The FDA issued a decision of Substantially Equivalent on May 17, 1985. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Cormed, Inc., Sub. C.R.Bard, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 1985
- Date Received
- March 8, 1985
- 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