The following data is part of a premarket notification filed by Medical Components, Inc (dba Medcomp_ with the FDA for C3 Wave System.
| Device ID | K170934 |
| 510k Number | K170934 |
| Device Name: | C3 Wave System |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Medical Components, Inc (Dba Medcomp_ 1499 Delp Drive Harleysville, PA 19438 |
| Contact | Courtney Nix |
| Correspondent | Courtney Nix Medical Components, Inc (Dba Medcomp_ 1499 Delp Drive 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 | 2017-03-30 |
| Decision Date | 2017-12-06 |
| Summary: | summary |