510(k) K864552
K864552 is an FDA 510(k) premarket notification submitted by Pharmacia, Inc. for the device "PORT-A-CATH IMPLANTABLE CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 31, 1987. The device falls under product code LLD (Port & Catheter, Implanted, Subcutaneous, Intraperitoneal), a Class II device regulated under 21 CFR 880.5965. Pharmacia, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1987
- Date Received
- November 19, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
- Device Class
- Class II
- Regulation Number
- 880.5965
- Review Panel
- HO
- Submission Type