The following data is part of a premarket notification filed by Medcomp ( Medical Components) with the FDA for Medcomp Vessel Dilator.
| Device ID | K162389 |
| 510k Number | K162389 |
| Device Name: | Medcomp Vessel Dilator |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MEDCOMP ( MEDICAL COMPONENTS) 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Courtney Nix |
| Correspondent | Courtney Nix MEDCOMP ( MEDICAL COMPONENTS) 1499 DELP DRIVE Harleysville, PA 19438 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-26 |
| Decision Date | 2017-06-01 |
| Summary: | summary |