510(k) K011916
K011916 is an FDA 510(k) premarket notification submitted by Horizon Medical Products, Inc. for the device "SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES". The FDA issued a decision of Substantially Equivalent on Oct 31, 2001. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Horizon Medical Products, Inc. has 15 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 31, 2001
- Date Received
- Jun 20, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Hemodialysis, Implanted
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type
- 510(k)