K011576 is an FDA 510(k) clearance for the MEDCOMP ASH SPLIT. This device is classified as a Kit, Repair, Catheter, Hemodialysis (Class II - Special Controls, product code NFK).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on June 21, 2001, 30 days after receiving the submission on May 22, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540. Hemodialysis Tray.
| 510(k) Number | K011576 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2001 |
| Decision Date | June 21, 2001 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NFK — Kit, Repair, Catheter, Hemodialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |
| Definition | Hemodialysis Tray |