The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quinton Q-cath, Model 000460.
| Device ID | K021906 |
| 510k Number | K021906 |
| Device Name: | QUINTON Q-CATH, MODEL 000460 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Contact | Karen Browne |
| Correspondent | Karen Browne QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-10 |
| Decision Date | 2002-09-04 |
| Summary: | summary |