The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Rt. Artrial And 13.5x11.5f Cath. Tray.
| Device ID | K885188 |
| 510k Number | K885188 |
| Device Name: | MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. 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 | 1988-12-07 |
| Decision Date | 1989-02-06 |