K971925 is an FDA 510(k) clearance for the MEDCOMP BIO-FLEX CS CATHETER (CS100). 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 23, 1998, 276 days after receiving the submission on May 23, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K971925 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 1997 |
| Decision Date | February 23, 1998 |
| Days to Decision | 276 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 |