The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Right Atrial Catheter Insertion Tray.
| Device ID | K881352 |
| 510k Number | K881352 |
| Device Name: | RIGHT ATRIAL CATHETER INSERTION TRAY |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Ron R Duck |
| Correspondent | Ron R Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-30 |
| Decision Date | 1988-06-09 |