The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Vessel Dilator.
| Device ID | K904476 |
| 510k Number | K904476 |
| Device Name: | VESSEL DILATOR |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Contact | Robert B Schock |
| Correspondent | Robert B Schock DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-01 |
| Decision Date | 1990-12-10 |