K983511 is an FDA 510(k) clearance for the SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH. 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 June 8, 1999, 244 days after receiving the submission on October 7, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K983511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1998 |
| Decision Date | June 08, 1999 |
| Days to Decision | 244 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 |