The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp Bio-flex Cs Catheter (cs100).
| Device ID | K971925 |
| 510k Number | K971925 |
| Device Name: | MEDCOMP BIO-FLEX CS CATHETER (CS100) |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Jeanne Cush |
| Correspondent | Jeanne 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 | 1997-05-23 |
| Decision Date | 1998-02-23 |