The following data is part of a premarket notification filed by Medical Components Inc with the FDA for Hemo-cath 10f, Hemo-cath 12.5f.
| Device ID | K113487 |
| 510k Number | K113487 |
| Device Name: | HEMO-CATH 10F, HEMO-CATH 12.5F |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Jean Callow |
| Correspondent | Jean Callow MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville, PA 19438 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-23 |
| Decision Date | 2012-03-09 |
| Summary: | summary |