510(k) K010189
K010189 is an FDA 510(k) premarket notification submitted by Horizon Medical Products, Inc. for the device "VORTEX ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 12, 2001. 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
- SESE (Substantially Equivalent)
- Decision Date
- Feb 12, 2001
- Date Received
- Jan 22, 2001
- 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
- 510(k)