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 | K180567 |
| 510k Number | K180567 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15051684020862 | K180567 | 000 |
| 15051684027236 | K180567 | 000 |
| H787MRC3RD0041 | K180567 | 000 |
| H787MRC3RD0031 | K180567 | 000 |
| H787MRC3RD0001 | K180567 | 000 |
| 15051684027199 | K180567 | 000 |
| 15051684027168 | K180567 | 000 |
| 15051684029810 | K180567 | 000 |
| 15051684029803 | K180567 | 000 |
| 15051684027243 | K180567 | 000 |
| 15051684027267 | K180567 | 000 |
| 15051684027274 | K180567 | 000 |
| 15051684020855 | K180567 | 000 |
| 15051684027397 | K180567 | 000 |
| 15051684027380 | K180567 | 000 |
| 15051684027373 | K180567 | 000 |
| 15051684027366 | K180567 | 000 |
| 15051684027359 | K180567 | 000 |
| 15051684027328 | K180567 | 000 |
| 15051684027311 | K180567 | 000 |
| 15051684029797 | K180567 | 000 |