510(k) K112477
K112477 is an FDA 510(k) premarket notification submitted by Covidien for the device "PALINDROME H, SI, HSI CHRONIC CATHETER". The FDA issued a decision of Substantially Equivalent (kit) on September 28, 2011. The device falls under product code NYU (Catheter, Hemodialysis, Implanted, Coated), a Class II device regulated under 21 CFR 876.5540. Covidien has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- September 28, 2011
- Date Received
- August 29, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Hemodialysis, Implanted, Coated
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type
Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.