510(k) K934573
K934573 is an FDA 510(k) premarket notification submitted by Horizon Medical Products, Inc. for the device "HMP TITANIUM LOW PROFILE PORT". The FDA issued a decision of Substantially Equivalent - Kit on Feb 25, 1994. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Horizon Medical Products, Inc. has 15 other 510(k) clearances on record.
Clearance details
- Decision
- SESK (Substantially Equivalent - Kit)
- Decision Date
- Feb 25, 1994
- Date Received
- Sep 21, 1993
- 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
- 510(k)