K112477 is an FDA 510(k) clearance for the PALINDROME H, SI, HSI CHRONIC CATHETER. This device is classified as a Catheter, Hemodialysis, Implanted, Coated (Class II - Special Controls, product code NYU).
Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on September 28, 2011, 30 days after receiving the submission on August 29, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540. Accessing The Central Vascular System For Long Term Hemodialysis While Reducing Infection Or Thrombogenesis..
| 510(k) Number | K112477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | August 29, 2011 |
| Decision Date | September 28, 2011 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NYU — Catheter, Hemodialysis, Implanted, Coated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |
| Definition | Accessing The Central Vascular System For Long Term Hemodialysis While Reducing Infection Or Thrombogenesis. |