The following data is part of a premarket notification filed by Med-west, Inc. with the FDA for Single Needle Subclavian Vein Mwi250/260.
| Device ID | K831440 |
| 510k Number | K831440 |
| Device Name: | SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 |
| Classification | Cannula, A-v Shunt |
| Applicant | MED-WEST, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FIQ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-05 |
| Decision Date | 1983-06-03 |