510(k) K031718
K031718 is an FDA 510(k) premarket notification submitted by Horizon Medical Products, Inc. for the device "LIFEVALVE CENTRAL VENOUS CATHTER". The FDA issued a decision of Substantially Equivalent on Jul 2, 2003. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Horizon Medical Products, Inc. has 15 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 2, 2003
- Date Received
- Jun 3, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type
- 510(k)