The following data is part of a premarket notification filed by Microvena Corp. with the FDA for Solostick (amplatz Dilator Needle).
| Device ID | K896096 |
| 510k Number | K896096 |
| Device Name: | SOLOSTICK (AMPLATZ DILATOR NEEDLE) |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MICROVENA CORP. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy MICROVENA CORP. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-20 |
| Decision Date | 1990-04-10 |