The following data is part of a premarket notification filed by Mc3 Incorporated with the FDA for Mc3 Jugular Dual Lumen Catheter.
| Device ID | K180151 |
| 510k Number | K180151 |
| Device Name: | MC3 Jugular Dual Lumen Catheter |
| Classification | Dual Lumen Ecmo Cannula |
| Applicant | MC3 Incorporated 2555 Bishop Circle West Dexter, MI 48130 |
| Contact | Adam Viitala |
| Correspondent | Adam Viitala MC3 Incorporated 2555 Bishop Circle West Dexter, MI 48130 |
| Product Code | PZS |
| CFR Regulation Number | 870.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-19 |
| Decision Date | 2018-07-16 |
| Summary: | summary |