K180567 is an FDA 510(k) clearance for the C3 Wave System. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on April 12, 2018, 38 days after receiving the submission on March 5, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K180567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2018 |
| Decision Date | April 12, 2018 |
| Days to Decision | 38 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |