The following data is part of a premarket notification filed by Medcomp with the FDA for 14.5f X 55cm Hemo-flow Double Lumen Catheter, Models Hfs-55, Hft-55.
| Device ID | K030502 |
| 510k Number | K030502 |
| Device Name: | 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Meghan J Tintle |
| Correspondent | Meghan J Tintle MEDCOMP 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 | 2003-02-19 |
| Decision Date | 2003-05-20 |
| Summary: | summary |