The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Repair Kit Quinton Triple Lumen Right Atrial Cathe.
| Device ID | K853860 |
| 510k Number | K853860 |
| Device Name: | REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE |
| Classification | Catheter, Percutaneous |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Donald L Andersen |
| Correspondent | Donald L Andersen QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-17 |
| Decision Date | 1985-10-18 |