The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Q-port System Kit.
| Device ID | K894650 |
| 510k Number | K894650 |
| Device Name: | Q-PORT SYSTEM KIT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Ron Duck |
| Correspondent | Ron Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1990-03-12 |