The following data is part of a premarket notification filed by Cardiac Assist, Inc. with the FDA for Protek Duo 31 Fr. Veno-venous Cannula Set.
| Device ID | K160257 |
| 510k Number | K160257 |
| Device Name: | PROTEK Duo 31 Fr. Veno-Venous Cannula Set |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CARDIAC ASSIST, INC. 240 ALPHA DRIVE Pittsburgh, PA 15238 |
| Contact | Greg Johnson |
| Correspondent | Greg Johnson CARDIAC ASSIST, INC. 240 ALPHA DRIVE Pittsburgh, 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 | 2016-02-01 |
| Decision Date | 2016-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814112020319 | K160257 | 000 |