510(k) K062901
K062901 is an FDA 510(k) premarket notification submitted by Med-Conduit, Inc. for the device "HEMOCATH II". The FDA issued a decision of Substantially Equivalent on February 8, 2007. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Med-Conduit, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2007
- Date Received
- September 27, 2006
- 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