The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp Z-cath.
| Device ID | K003682 |
| 510k Number | K003682 |
| Device Name: | MEDCOMP Z-CATH |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-30 |
| Decision Date | 2001-01-26 |