The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp 14.5f Double Lumen Hemodialysis Catheter.
| Device ID | K012562 |
| 510k Number | K012562 |
| Device Name: | MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Florence A Caikoski |
| Correspondent | Florence A Caikoski MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-08 |
| Decision Date | 2002-02-08 |
| Summary: | summary |