K062671 is an FDA 510(k) clearance for the 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE). This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by Kendall (Mansfield, US). The FDA issued a Cleared decision on November 3, 2006, 56 days after receiving the submission on September 8, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K062671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | September 08, 2006 |
| Decision Date | November 03, 2006 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSD — Catheter, Hemodialysis, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |