510(k) K092205
K092205 is an FDA 510(k) premarket notification submitted by Covidien Lp, Formerly Registered AS Kendall for the device "PALINDROME P HEMODIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent (kit) on October 30, 2009. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Covidien Lp, Formerly Registered AS Kendall has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- October 30, 2009
- Date Received
- July 22, 2009
- 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