The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Quinton Single Lumen Catheter.
| Device ID | K896252 |
| 510k Number | K896252 |
| Device Name: | MODIFIED QUINTON SINGLE LUMEN CATHETER |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Contact | Randy Walls |
| Correspondent | Randy Walls QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-30 |
| Decision Date | 1990-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521794754 | K896252 | 000 |
| 20884521794747 | K896252 | 000 |
| 20884521794730 | K896252 | 000 |
| 20884521056746 | K896252 | 000 |
| 20884521056760 | K896252 | 000 |