The following data is part of a premarket notification filed by Covidien with the FDA for Rapidvac Smoke Evacuator System.
| Device ID | K142335 |
| 510k Number | K142335 |
| Device Name: | RapidVac Smoke Evacuator System |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfiled, MA 02048 |
| Contact | Jose Marquez |
| Correspondent | Jose Marquez COVIDIEN 15 HAMPSHIRE STREET Mansfiled, MA 02048 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-21 |
| Decision Date | 2015-01-14 |
| Summary: | summary |