The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Raaf Dual Lumen Catheter.
| Device ID | K842176 |
| 510k Number | K842176 |
| Device Name: | RAAF DUAL LUMEN CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | QUINTON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-08 |
| Decision Date | 1984-07-13 |