K113487 is an FDA 510(k) clearance for the HEMO-CATH 10F, HEMO-CATH 12.5F. This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on March 9, 2012, 107 days after receiving the submission on November 23, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K113487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | November 23, 2011 |
| Decision Date | March 09, 2012 |
| Days to Decision | 107 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 |