K981125 is an FDA 510(k) clearance for the MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6. 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 February 26, 1999, 336 days after receiving the submission on March 27, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K981125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1998 |
| Decision Date | February 26, 1999 |
| Days to Decision | 336 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MSD — Catheter, Hemodialysis, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |