510(k) K002901
K002901 is an FDA 510(k) premarket notification submitted by The Kendall Company for the device "KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER". The FDA issued a decision of Substantially Equivalent on March 28, 2001. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. The Kendall Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2001
- Date Received
- September 18, 2000
- 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