The following data is part of a premarket notification filed by Endovascular Instruments, Inc. with the FDA for Peripheral Vascular Dilator.
| Device ID | K974617 |
| 510k Number | K974617 |
| Device Name: | PERIPHERAL VASCULAR DILATOR |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | ENDOVASCULAR INSTRUMENTS, INC. 1800 EAST 900 SOUTH Saltlake City, UT 84108 |
| Contact | Jack Speer |
| Correspondent | Jack Speer ENDOVASCULAR INSTRUMENTS, INC. 1800 EAST 900 SOUTH Saltlake City, UT 84108 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-11 |
| Decision Date | 1998-12-01 |
| Summary: | summary |