C3 Wave
Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
MEDCOMP (MEDICAL COMPONENTS)
The following data is part of a premarket notification filed by Medcomp (medical Components) with the FDA for C3 Wave.
Pre-market Notification Details
| Device ID | K143238 |
| 510k Number | K143238 |
| Device Name: | C3 Wave |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-12 |
| Decision Date | 2015-04-24 |
| Summary: | summary |
Trademark Results [C3 Wave]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 C3 WAVE 87428175 5944556 Live/Registered |
Medical Components, Inc. 2017-04-27 |
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