The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for 11.5f X 6 (15cm) Duo-split Catheter Mcds116mt, 11.5f X 8 (20cm) Duo-split Catheter Mcds118mt.
| Device ID | K980438 |
| 510k Number | K980438 |
| Device Name: | 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Jeanne M Cush |
| Correspondent | Jeanne M Cush MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-04 |
| Decision Date | 1999-06-10 |