The following data is part of a premarket notification filed by Impra, Inc. with the FDA for 10 And 12 French Vessel Dilators.
| Device ID | K874738 |
| 510k Number | K874738 |
| Device Name: | 10 AND 12 FRENCH VESSEL DILATORS |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Contact | James M Mchaney |
| Correspondent | James M Mchaney IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-18 |
| Decision Date | 1988-05-02 |