The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Instruction Change For Right Atrial/raaf Catheter.
| Device ID | K864949 |
| 510k Number | K864949 |
| Device Name: | INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Randy Walls |
| Correspondent | Randy Walls QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-05 |
| Decision Date | 1987-02-25 |