The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Hemo-flow Double Lumen Catheter, Models Hfs-24, Hfs-28, Hfs-32, Hfs-36, Hfs-40.
| Device ID | K994105 |
| 510k Number | K994105 |
| Device Name: | HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 |
| Classification | Catheter, Hemodialysis, 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 | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-06 |
| Decision Date | 2001-10-03 |
| Summary: | summary |