The following data is part of a premarket notification filed by 3t Medical Systems, Llc. with the FDA for 3t Vessel Cannulas.
| Device ID | K020768 |
| 510k Number | K020768 |
| Device Name: | 3T VESSEL CANNULAS |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | 3T MEDICAL SYSTEMS, LLC. 12553 S. WAMBLEE VALLEY RD. Conifer, CO 80433 -6204 |
| Contact | Robert P Eaton |
| Correspondent | Robert P Eaton 3T MEDICAL SYSTEMS, LLC. 12553 S. WAMBLEE VALLEY RD. Conifer, CO 80433 -6204 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-07 |
| Decision Date | 2002-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817278011983 | K020768 | 000 |
| 10817278011976 | K020768 | 000 |
| 10817278010139 | K020768 | 000 |
| 10864039000410 | K020768 | 000 |