The following data is part of a premarket notification filed by Med-west, Inc. with the FDA for Sheath/dilators.
| Device ID | K872724 |
| 510k Number | K872724 |
| Device Name: | SHEATH/DILATORS |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MED-WEST, INC. P.O. BOX 26851 Salt Lake City, UT 84126 |
| Contact | Dave Beattie |
| Correspondent | Dave Beattie MED-WEST, INC. P.O. BOX 26851 Salt Lake City, UT 84126 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-08 |
| Decision Date | 1987-09-15 |