K113487 is an FDA 510(k) clearance for the HEMO-CATH 10F, HEMO-CATH 12.5F, 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 review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K113487 FDA.gov |
| FDA Decision | Cleared 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 |