The following data is part of a premarket notification filed by Mc3 Incorporated with the FDA for Mc3 Quickflow Dual Lumen Catheter.
| Device ID | K171610 |
| 510k Number | K171610 |
| Device Name: | MC3 QuickFlow Dual Lumen Catheter |
| Classification | Dual Lumen Ecmo Cannula |
| Applicant | MC3 Incorporated 2555 Bishop Circle West Dexter, MI 48130 |
| Contact | Martha Rumford |
| Correspondent | Martha Rumford 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 | 2017-06-01 |
| Decision Date | 2017-11-16 |
| Summary: | summary |