K130851 is an FDA 510(k) clearance for the CASCADE HEMODIALYSIS/APHERESIS CATHETER. This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by Health Line International Corporation (Centerville, US). The FDA issued a Cleared decision on January 9, 2014, 288 days after receiving the submission on March 27, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K130851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | March 27, 2013 |
| Decision Date | January 09, 2014 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| 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 |