The following data is part of a premarket notification filed by Cardiacassist Inc with the FDA for Protekduo Mini Veno-venous Cannula Set.
| Device ID | K181150 |
| 510k Number | K181150 |
| Device Name: | ProtekDuo Mini Veno-Venous Cannula Set |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CardiacAssist Inc 240 Alpha Drive Pittsburg, PA 15238 |
| Contact | Greg Johnson |
| Correspondent | Greg Johnson CardiacAssist Inc 240 Alpha Drive Pittsburg, PA 15238 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2018-05-25 |
| Summary: | summary |