K923691 is an FDA 510(k) clearance for the TWIN SILICONE CATHETER. This device is classified as a Catheter, Hemodialysis, Non-implanted (Class II - Special Controls, product code MPB).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on September 25, 1995, 1159 days after receiving the submission on July 23, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K923691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | July 23, 1992 |
| Decision Date | September 25, 1995 |
| Days to Decision | 1159 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | MPB — Catheter, Hemodialysis, Non-implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |